2.  Peer Reviewed Title: Ovarian activity and safety of a novel levonorgestrel/ethinyl estradiol continuous oral contraceptive regimen. Author: Archer DF; Kovalevsky G; Ballagh SA; Grubb GS Source: Contraception. 2009 Sep;80(3):245-53. Abstract: BACKGROUND: A continuous regimen of oral levonorgestrel (LNG) 90 mcg/ethinyl estradiol (EE) 20 mcg was evaluated for inhibition of ovulation, time to return to ovulation after stopping treatment and safety. STUDY DESIGN: This open-label study was conducted in healthy women aged 18-35 years. Ovulation was documented before treatment, and then participants received oral tablets containing LNG 90 mcg/EE 20 mcg to be taken continuously for three 28-day intervals. Ovarian activity was assessed three times per week during the treatment period with transvaginal ultrasound scans and measurements of serum 17beta-estradiol, progesterone, follicle-stimulating hormone and luteinizing hormone concentrations. Safety assessments included physical examinations, laboratory evaluations and adverse event records. RESULTS: Thirty-seven of the 58 subjects who received treatment met predefined criteria for efficacy analysis. No on-treatment ovulations occurred in the efficacy or intent-to-treat population. There was evidence of ovulation within 37 days of stopping treatment for 46 (98%) of 47 subjects evaluated posttreatment. The final subject with a history of polycystic ovarian syndrome ovulated by Day 66. The safety profile observed during this 84-day continuous regimen was similar to that seen with other low-dose oral contraceptives administered in a cyclic regimen. CONCLUSIONS: The continuous LNG/EE regimen completely inhibited ovulation, with little evidence of follicular development and with rapid return of ovulatory capacity after stopping treatment. Language: English Keywords: UNITED STATES OF AMERICA | RESEARCH REPORT | WOMEN | ORAL CONTRACEPTIVES | LEVONORGESTREL | ETHINYL ESTRADIOL | SAFETY | ULTRASONICS | OVARIAN EFFECTS | TREATMENT | Developed Countries | North America | Americas | Demographic Factors | Population | Contraceptive Methods | Contraception | Family Planning | Contraceptive Agents, Progestin | Contraceptive Agents, Female | Contraceptive Agents | Contraceptive Agents, Estrogen | Public Health | Health | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Ovary | Genitalia, Female | Genitalia | Urogenital System | Physiology | Biology Document Number: 342575 |
| 3. Peer Reviewed Title: Polycystic ovary syndrome and cardiovascular risk in young patients treated with drospirenone-ethinylestradiol or contraceptive vaginal ring. A prospective, randomized, pilot study. Author: Battaglia C; Mancini F; Fabbri R; Persico N; Busacchi P; Facchinetti F; Venturoli S Source: Fertility and Sterility. 2009 Jul 8; Abstract: OBJECTIVE: To compare the effects of a pill containing drospirenone with those of a combined contraceptive vaginal ring on the lipid and carbohydrate metabolism and on the surrogate markers of arterial function. SETTING: Bologna University School of Medicine. PATIENT(S): Thirty-seven women with polycystic ovary syndrome (PCOS) were randomly submitted to drospirenone + ethinylestradiol (group I; n = 19) or combined contraceptive vaginal ring (group II; n = 18) therapy. The duration of the study was 6 months. INTERVENTION(S): The effect of treatments was assessed after 6 months of therapy. MAIN OUTCOME MEASURE(S): Utero-ovarian ultrasound analysis and color Doppler evaluation of uterine and stromal ovarian arteries. In addition, analysis of brachial artery flow-mediated vasodilatation and 24-hour ambulatory blood pressure monitoring were performed. Fasting blood samples were drawn for testing biochemical and hormonal parameters and nitrites/nitrates. RESULT(S): Both treatments improved hirsutism, hyperandrogenemia, and ultrasound and color Doppler ovarian parameters. Both drospirenone + ethinylestradiol or contraceptive vaginal ring induced a slight but significant increase of diurnal and 24-hour blood pressure. Although both therapies worsened the lipid profile, the oral pill administration was associated with a more evident increase of circulating triglycerides. The 6-month treatment with the vaginal ring significantly improved the area under the curve for glucose, insulin, and C-peptide, whereas the drospirenone + ethinylestradiol pill induced an increase in the insulinogenic index and homeostatic model assessment estimate for insulin resistance values. CONCLUSION(S): Vaginal hormonal contraception appears to be preferable to oral ethinylestradiol + drospirenone administration in hyperinsulinemic patients with PCOS. Language: English Keywords: ITALY | RESEARCH REPORT | PROSPECTIVE STUDIES | COMPARATIVE STUDIES | CLIENTS | OVARIAN CYSTS | ORAL CONTRACEPTIVES, COMBINED | ETHINYL ESTRADIOL | LOW-DOSE PROGESTINS | VAGINAL RING | CARDIOVASCULAR EFFECTS | CARBOHYDRATE METABOLIC EFFECTS | LIPID METABOLIC EFFECTS | BLOOD PRESSURE | ULTRASONICS | Developed Countries | Europe, Southern | Europe | Studies | Research Methodology | Program Activities | Programs | Organization and Administration | Diseases | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Contraceptive Agents, Estrogen | Contraceptive Agents, Female | Contraceptive Agents | Contraceptive Agents, Progestin | Physiology | Biology | Metabolic Effects | Lipids | Hemic System | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health Document Number: 342128 |
| 4. Title: Added benefits and user satisfaction with a low-dose oral contraceptive containing drospirenone : results of three multicentre trials. Author: Bitzer J; Paoletti AM Source: Clinical Drug Investigation. 2009;29(2):73-8. Abstract: The ethinylestradiol 20 mug/drospirenone 3 mg combined oral contraceptive (COC), administered in cycles of 21 days continuous use followed by a 7-day hormone-free interval (21/7) [Yasminelle((R))], has been proven to be an effective and well tolerated contraceptive with an acceptable bleeding pattern and good safety profile. In addition, the ethinylestradiol 20 mug/drospirenone 3 mg 21/7 COC prevents water-retention-related weight gain, and improves physical and emotional well-being, consistent with other drospirenone-containing COCs. In clinical studies, >85% of those who received the ethinylestradiol 20 mug/drospirenone 3 mg 21/7 COC were satisfied or very satisfied with this contraceptive. The positive attributes of the ethinylestradiol 20 mug/drospirenone 3 mg 21/7 COC beyond contraceptive protection may have important implications for improving treatment compliance and reducing treatment discontinuation. Physical well-being stayed the same or improved during use of this COC in 56% and 34% of women, respectively. Emotional well-being stayed the same or improved in 71% and 20% of women, respectively. Language: English Keywords: ITALY | RESEARCH REPORT | PROSPECTIVE STUDIES | WOMEN | ORAL CONTRACEPTIVES | ETHINYL ESTRADIOL | ORAL CONTRACEPTIVES, COMBINED | CONTRACEPTIVE EFFECTIVENESS | SATISFACTION | Developed Countries | Europe, Southern | Europe | Studies | Research Methodology | Demographic Factors | Population | Contraceptive Methods | Contraception | Family Planning | Contraceptive Agents, Estrogen | Contraceptive Agents, Female | Contraceptive Agents | Psychological Factors | Behavior Document Number: 329809 |
| 5. Peer Reviewed Title: Twenty or thirty microgram ethinyloestradiol in an oral contraceptive: Does it make a difference in the mind and the daily practice of gynaecologists and general practitioners? Author: Bitzer J; Frey B; von Schonau M; Sabler N; Tschudin S Source: European Journal of Contraception and Reproductive Health Care. 2009 Jun 5;:1-10. Abstract: Objectives Currently, evidence-based guidelines concerning the use of oral contraceptives (OCs) containing either 20 or 30 mug ethinyloestradiol (EE) and the same progestogen, are lacking. We wanted to identify whether Swiss gynaecologists and general practitioners (GPs) have specific criteria on which they base their prescribing habit. Methods Two questionnaires were submitted to 158 physicians. The first one contained a list of possible criteria relevant for decision making and a description of specific clinical situations. The second one concerned actual patients who received either a 20 mug (Yasminelle(R)) or a 30 mug (Yasmin(R)) OC containing the same progestogen drospirenone. Results The most relevant criteria for decision making (in hierarchical order) were family history of venous thromboembolic disease (VTE), headache, smoking, age beyond 35, stability of the menstrual cycle, breast tenderness, body mass index, irregular bleeding and acne. The 20 mug dosage was preferred for women older than 35, those smoking more than 15 cigarettes per day, those with a family history of VTE, and those complaining of breast tenderness or headache. The 30 mug dosage was preferred for patients with a history of irregular bleeding, a family history of osteoporosis, expected poor compliance and acne. Conclusion Swiss gynaecologists and GPs do not preferentially prescribe the lowest possible dosage of EE. They use indirect markers they consider relevant for differential prescribing. For some markers, there is inconsistency, indicating that preferences for 20 mug and 30 mug preparations may be influenced by other factors. Language: English Keywords: SWITZERLAND | RESEARCH REPORT | PHYSICIANS | WOMEN | CLIENTS | DECISION MAKING | TOBACCO USE | HEADACHE | ORAL CONTRACEPTIVES | ETHINYL ESTRADIOL | CONTRACEPTIVE AGENTS, SIDE EFFECTS | THROMBOEMBOLISM | AGE FACTORS | ADMINISTRATION AND DOSAGE | Developed Countries | Europe, Central | Europe | Health Personnel | Delivery of Health Care | Health | Demographic Factors | Population | Program Activities | Programs | Organization and Administration | Behavior | Signs and Symptoms | Diseases | Contraceptive Methods | Contraception | Family Planning | Contraceptive Agents, Estrogen | Contraceptive Agents, Female | Contraceptive Agents | Embolism | Vascular Diseases | Population Characteristics | Drugs | Treatment | Medical Procedures | Medicine | Health Services Document Number: 341601 |
| 6. Title: Influence of transdermal rotigotine on ovulation suppression by a combined oral contraceptive. Author: Braun M; Elshoff JP; Andreas JO; Muller LI; Horstmann R Source: British Journal of Clinical Pharmacology. 2009 Sep;68(3):386-94. Abstract: AIMS: To assess the influence of the transdermally applied dopamine agonist rotigotine on ovulation suppression by a combined oral contraceptive (0.03 mg ethinyloestradiol and 0.15 mg levonorgestrel) in a randomized, double-blind crossover study in 40 healthy females. METHODS: Treatment A consisted of the combined oral contraceptive for 28 days plus rotigotine for the first 13 days (2 mg (24 h)(-1) on days 1-3, 3 mg (24 h)(-1) maintenance dose thereafter). During treatment B, subjects received matching placebo patches instead of rotigotine. Pharmacodynamic parameters (progesterone, oestradiol, luteinizing hormone, and follicle stimulating hormone serum concentrations), pharmacokinetic parameters for ethinyloestradiol/levonorgestrel and rotigotine, and safety and tolerability of the treatment were assessed. RESULTS: Progesterone serum concentrations remained below 2 ng ml(-1) in all subjects during the luteal phase. Median serum concentrations of all other pharmacodynamic parameters were similar during both treatments. Pharmacokinetic parameters C(max,ss) and AUC(0,24 h)(ss) at steady state were similar with or without co-administration of rotigotine for both ethinyloestradiol and levonorgestrel with geometric mean ratios close to 1 and 90% confidence intervals within the acceptance range of bioequivalence (0.8, 1.25): C(max,ss) 1.05 (0.93, 1.19), AUC(0,24 h)(ss) 1.05 (0.9, 1.22) for ethinyloestradiol; C(max,ss) 1.01 (0.96, 1.06), AUC(0,24 h)(ss) 0.98 (0.95, 1.01) for levonorgestrel. Mean plasma concentrations of unconjugated rotigotine remained stable throughout the patch-on period (day 13). CONCLUSIONS: Concomitant administration of 3 mg (24 h)(-1) transdermal rotigotine had no impact on the pharmacodynamics and pharmacokinetics of a combined oral contraceptive containing 0.03 mg ethinyloestradiol and 0.15 mg levonorgestrel, suggesting that the dopamine agonist does not influence contraception efficacy. Language: English Keywords: SOUTH AFRICA | SUMMARY REPORT | WOMEN | ORAL CONTRACEPTIVES, COMBINED | LEVONORGESTREL | ETHINYL ESTRADIOL | ADMINISTRATION AND DOSAGE | CONTRACEPTIVE SAFETY | TREATMENT | Developing Countries | Africa, Southern | Africa, Sub Saharan | Africa | Demographic Factors | Population | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Contraceptive Agents, Progestin | Contraceptive Agents, Female | Contraceptive Agents | Contraceptive Agents, Estrogen | Drugs | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Safety | Public Health Document Number: 342711 |
| 7. Peer Reviewed Title: Association between efficacy and body weight or body mass index for two low-dose oral contraceptives. Author: Burkman RT; Fisher AC; Wan GJ; Barnowski CE; LaGuardia KD Source: Contraception. 2009 Jun;79(6):424-7. Abstract: BACKGROUND: This analysis investigated the association of oral contraceptive efficacy with body weight and body mass index (BMI) for hypothesis-generating purposes. STUDY DESIGN: Data were from a randomized, parallel-group trial of 180/215/250 mcg of norgestimate (NGM)/25 mcg of ethinyl estradiol (EE) (given to 1671 women) and 1 mg of norethindrone acetate (NETA)/20 mcg of EE (given to 1139 women). Pregnancies were evaluated across BMI deciles and by BMI and body weight dichotomies. A Pearl index was calculated for each treatment group. The relative risk (RR) of pregnancy was calculated with a Cox proportional hazards model. RESULTS: The Pearl index for women who received NGM/EE was 2.36 [95% confidence interval (CI)=1.33-3.40]; for those who received NETA/EE, the Pearl index was 3.29 (95% CI=1.81-4.77). Consistent, weak positive associations between weight and pregnancy risk were found. Overall, for women with a BMI >or=25 kg/m(2) (compared with women with a BMI <25 kg/m(2)), the RR of pregnancy was 1.84 (95% CI=0.98-3.45); that for women who received NGM/EE was 1.39 (95% CI=0.57-3.40), whereas that for women who received NETA/EE was 2.49 (95% CI=1.01-6.13). For women with a body weight >or=70 kg (compared with women with a body weight <70 kg), the RR was 1.25 (95% CI=0.63-2.46); that for women who received NGM/EE was 1.41 (95% CI=0.56-3.54), whereas that for women who received NETA/EE was 1.12 (95% CI=0.40-3.12). CONCLUSION: Women in the higher body weight or BMI category showed a small increase in the risk of pregnancy with these oral contraceptives, but this increase was not statistically significant overall or for either formulation studied. Language: English Keywords: UNITED STATES OF AMERICA | RESEARCH REPORT | CLINICAL RESEARCH | COMPARATIVE STUDIES | WOMEN | CONTRACEPTIVE EFFECTIVENESS | BODY WEIGHT | NORGESTIMATE | ETHINYL ESTRADIOL | ORAL CONTRACEPTIVES, COMBINED | NORETHINDRONE ACETATE | ADMINISTRATION AND DOSAGE | Developed Countries | North America | Americas | Research Methodology | Studies | Demographic Factors | Population | Contraception | Family Planning | Physiology | Biology | Contraceptive Agents, Progestin | Contraceptive Agents, Female | Contraceptive Agents | Contraceptive Agents, Estrogen | Oral Contraceptives | Contraceptive Methods | Norethindrone | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health Document Number: 341104 |
| 8. Peer Reviewed Title: Satisfaction and compliance in hormonal contraception: the result of a multicentre clinical study on women's experience with the ethinylestradiol/norelgestromin contraceptive patch in Italy. Author: Crosignani PG; Nappi C; Ronsini S; Bruni V; Marelli S; Sonnino D; Study Group IE Source: BMC Women's Health. 2009 Jun 30;9(1):18. Abstract: ABSTRACT: BACKGROUND: For many women finding the right contraceptive method can be challenging and consistent and correct use over a lifetime is difficult. Even remembering to take a birth control pill every day can be a challenge. The primary objective of this study was to evaluate women's experience with a weekly ethinylestradiol/norelgestromin contraceptive patch (EE/NGMN patch), given new technologies recently developed in hormonal contraception to increase women's options in avoiding daily dosing. METHODS: In 24 Italian sites, 207 women received the EE/NGMN patch for up to 6 cycles. At study end, overall satisfaction and preference, as well as compliance, efficacy and safety, were evaluated. RESULTS: 175 women (84.5%) completed the study. The overall satisfaction rate was 88%; convenience and once-a-week frequency of the patch were especially appreciated. At baseline, 82 women (39.4%) were using a contraceptive method, mainly oral contraceptives and barrier methods, but only 45.1% were very satisfied/satisfied; after 6 months with the patch, 86.3% of this subset was very satisfied/satisfied. Considering the method used in the 3 months before the study entry, 78.1% strongly preferred/preferred the patch, for convenience (53.9%), ease of use/simplicity (28.9%), fewer (9.2%) and less severe (2.6%) side effects. Compliance was very high: 1034/1110 cycles (93.2%) were completed with perfect compliance and the mean subject's compliance score was 90%. One on-therapy pregnancy occurred. The patch was safe and well tolerated: adverse events frequency was low, with predominantly single reports of each event. Most of them started and subsided during cycle 1. CONCLUSIONS: This study demonstrated that the EE/NGMN patch is associated with high satisfaction levels and excellent compliance. At study end, the majority of women indicated that they would continue using the patch. Language: English Keywords: ITALY | RESEARCH REPORT | FAMILY PLANNING ACCEPTORS | CONTRACEPTION RESEARCH | CONTRACEPTIVE METHODS | ETHINYL ESTRADIOL | CONTRACEPTIVE AGENTS, PROGESTIN | CONTRACEPTIVE EFFECTIVENESS | CONTRACEPTIVE SAFETY | SATISFACTION | USER COMPLIANCE | Developed Countries | Europe, Southern | Europe | Family Planning Programs | Family Planning | Contraception | Contraceptive Agents, Estrogen | Contraceptive Agents, Female | Contraceptive Agents | Safety | Public Health | Health | Psychological Factors | Behavior Document Number: 341863 |
| 9. Peer Reviewed Title: Effects of oral contraception with ethinylestradiol and drospirenone on oxidative stress in women 18-35 years old. Author: De Groote D; d'Hauterive SP; Pintiaux A; Balteau B; Gerday C; Claesen J; Foidart JM Source: Contraception. 2009 Aug;80(2):187-93. Abstract: BACKGROUND: Oral contraceptives (OCs) with estrogens and progestins may affect oxidative stress (OS) status. STUDY DESIGN: A group of 32 women using oral contraceptives (OCU) containing 0.03 mg ethinylestradiol and 3 mg drospirenone have been compared to a matched control group of 30 noncontraception users (NCU). Blood levels of antioxidants, trace elements and markers of lipid peroxidation were assessed by biochemical methods. A microarray analysis of whole blood mRNA levels of 200 genes involved in OS-dependant pathway was also performed. RESULTS: Levels of zinc, vitamin E and antibodies to oxidized low-density lipoproteins (LDLs) were not significantly different between the two groups. On the other hand, significant increases in the mean levels of lipid peroxides (+176%, p<.001), oxidized LDLs (+145%, p<.002), copper (+103%, p<.001), Cu/Zn ratio (+100%, p<.001) and a significant decrease in the mean level of beta-carotene (-41%, p<.01) were observed in the OCU compared to NCU. There was a highly significant positive correlation between the lipid peroxide levels and the copper-to-zinc ratio. From the 200 genes tested by microarray, one coding for HSP70 was significantly up-regulated (log(2) fold change=+ 0.45, p<.02) and one coding for inducible nitric oxide synthase significantly down-regulated (log(2) fold change=-0.24, p<.05) in the OCU compared to the NCU. CONCLUSIONS: The recently introduced combination of ethinylestradiol and drospirenone induced the heightening of lipid peroxidation correlated with high levels of copper, a situation that could be associated with increased cardiovascular risk. Language: English Keywords: BELGIUM | RESEARCH REPORT | CONTROL GROUPS | WOMEN | ORAL CONTRACEPTIVES, COMBINED | ETHINYL ESTRADIOL | LOW-DOSE PROGESTINS | ORAL CONTRACEPTIVES, SIDE EFFECTS | METABOLIC EFFECTS | CARDIOVASCULAR EFFECTS | SERUM COPPER LEVEL | Europe, Western | Europe | Developed Countries | Research Methodology | Demographic Factors | Population | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Contraceptive Agents, Estrogen | Contraceptive Agents, Female | Contraceptive Agents | Contraceptive Agents, Progestin | Contraceptive Safety | Safety | Public Health | Health | Physiology | Biology | Hemic System Document Number: 342303 |
| 10. Peer Reviewed Title: Impact of obesity on oral contraceptive pharmacokinetics and hypothalamic-pituitary-ovarian activity. Author: Edelman AB; Carlson NE; Cherala G; Munar MY; Stouffer RL; Cameron JL; Stanczyk FZ; Jensen JT Source: Contraception. 2009 Aug;80(2):119-27. Abstract: BACKGROUND: This study was conducted to determine whether increased body mass index (BMI) affects oral contraceptive (OC) pharmacokinetics and suppression of hypothalamic-pituitary-ovarian (HPO) axis activity. STUDY DESIGN: Ovulatory reproductive-age women with normal weight (BMI <25 kg/m(2); n=10) and with obesity (BMI >30 kg/m(2); n=10) received OCs for two cycles (prospective cohort). Subjects were admitted for two 48-h inpatient stays at the beginning and end of the hormone-free interval. Ethinyl estradiol and levonorgestrel (LNG) levels were evaluated during both inpatient stays. Gonadotropin pulsatility (follicle-stimulating hormone and luteinizing hormone) was measured during the second inpatient stay. Estradiol (E(2)) and progesterone (P) were measured daily during inpatient stays and twice per week in Cycle 2. RESULTS: BMI was greater in the obese compared to the normal-BMI group [37.3 kg/m(2) (SD, 6.0) vs. 21.9 kg/m(2) (SD, 1.6); p<.05]. The LNG half-life was significantly longer in the obese group (52.1+/-29.4 vs. 25.6+/-9.3 h, p<.05), which correlated with a lower maximum LNG concentration on Cycle 2, Day 1 [1.9 ng/mL (SD, 0.5) vs. 2.5 ng/mL (SD, 0.7)] and a longer time to reach steady state (10 vs. 5 days) in obese women. There were no significant differences in volume of distribution between groups. LH pulse parameters did not differ statistically between groups but trended toward greater HPO activity in the obese group. Additionally, more obese (6/10 vs. 3/10 normal BMI, p>.05) women exhibited E(2) levels consistent with development of a dominant follicle and P levels consistent with ovulation (2/10 vs. 1/10) during Cycle 2. CONCLUSIONS: Compared to women with normal BMI, obese women exhibit differences in OC pharmacokinetics that are associated with greater HPO activity. Language: English Keywords: UNITED STATES OF AMERICA | RESEARCH REPORT | PROSPECTIVE STUDIES | WOMEN | OBESITY | ORAL CONTRACEPTIVES, COMBINED | CONTRACEPTION FAILURE | ETHINYL ESTRADIOL | LEVONORGESTREL | GONADOTROPINS, PITUITARY | LABORATORY PROCEDURES | TIME FACTORS | Developed Countries | North America | Americas | Studies | Research Methodology | Demographic Factors | Population | Body Weight | Physiology | Biology | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Contraceptive Usage | Contraceptive Agents, Estrogen | Contraceptive Agents, Female | Contraceptive Agents | Contraceptive Agents, Progestin | Gonadotropins | Hormones | Endocrine System | Laboratory Examinations and Diagnoses | Examinations and Diagnoses | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Population Dynamics Document Number: 342308 |
| 11. Title: [Efficacy and safety of drospirenone-ethinylestradiol on contraception in healthy chinese women: a multicenter randomized controlled trial] Author: Fan GS; Bian ML; Cheng LN; Cao XM; Huang ZR; Han ZY; Jing XP; Li J; Wu SY; Xiong CL; Xiong ZA; Yue TF Source: Zhonghua Fu Chan Ke Za Zhi. 2009 Jan;44(1):38-44. Abstract: OBJECTIVE: To evaluate the contraception efficacy, mode of bleeding, side effects and other positive effects of drospirenone-ethinylestradiol (Yasmin) in healthy Chinese women. METHODS: This was a multicenter, randomized, control study of 768 healthy Chinese women who consulted about contraception. The subjects were randomized into Yasmin group (30 microg ethinylestradiol plus 3 mg drospirenone, 573 cases) or desogestrel group (30 microg ethinylestradiol plus 150 microg desogestrel, 195 cases) with the ratio of 3:1. Each individual was treated for 13 cycles. Further visits were required at cycle 4, cycle 7, cycle 10 and cycle 13 of treatment Weight, height, body mass index were evaluated at each visit. The menstrual distress questionnaire (MDQ) was given to the women at baseline, visit 3 (cycle 7) and visit 5 (after cycle 13). RESULTS: The values of basal features were similar between two groups (P > 0.05). The Pearl index (method failure) of Yasmin was 0. 208/hundred women year which was lower than that of desogestrel (0. 601/hundred women year). The mode of bleeding was similar between two groups after trial without showing any significant difference. According to MDQ subscale, the improvement of water retention and increasing appetite during inter-menstrual period and water retention and general well-being during menstrual period in the Yasmin group (-0.297, -0.057, 0.033, 0.150 respectively) was more obvious than that in the desogestrel group (-0.108, 0.023, 0.231, -0.023 respectively) with a significant difference (P < 0.05). Some other values which improved in both two groups, especially the improvement of breast tenderness and pain and skin abnormality in Yasmin group (18.0%, 89/494; 12.6%, 62/494) was more distinct than that in desogestrel group (11.3%, 19/168; 5.4%, 9/168). The mean weight increased in desogestrel group (0.57 kg) while it decreased in Yasmin group (-0.28 kg) with a significant difference (P < 0.01). CONCLUSIONS: Both Yasmin and desogestrel have good efficacy on contraception and similar modes of menstrual bleeding. Yasmin is better than desogestrel in terms of weight control and premenstrual syndrome of oral contraceptive. Language: Chinese Keywords: CHINA | RESEARCH REPORT | WOMEN | PEARL'S FORMULA | BODY WEIGHT | BODY HEIGHT | MENSTRUATION DISORDERS | DESOGESTREL | ETHINYL ESTRADIOL | TREATMENT | TESTING | Asia, Eastern | Asia | Developing Countries | Demographic Factors | Population | Contraceptive Use-Effectiveness | Contraceptive Effectiveness | Contraception | Family Planning | Physiology | Biology | Diseases | Contraceptive Agents, Progestin | Contraceptive Agents, Female | Contraceptive Agents | Contraceptive Agents, Estrogen | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Measurement | Research Methodology Document Number: 341804 |
| 12. Title: Effects of the contraceptive patch, the vaginal ring and an oral contraceptive on APC resistance and SHBG: a cross-over study. Author: Fleischer K; van Vliet HA; Rosendaal FR; Rosing J; Tchaikovski S; Helmerhorst FM Source: Thrombosis Research. 2009;123(3):429-35. Abstract: INTRODUCTION: The transdermal patch (20 microg ethinylestradiol+150 microg norelgestromin daily) and the vaginal ring (15 microg ethinylestradiol+120 microg etonogestrel daily) are new contraceptives, designed to deliver a low dose of hormones, suggesting a low exposure. However, few data are available about their risk of venous thrombosis. The objective was to investigate the effect of the patch, the ring, and an oral contraceptive (30 microg ethinylestradiol+150 microg levonorgestrel daily) on activated protein C sensitivity ratio (APC-sr) and on sex hormone-binding globulin (SHBG) levels in plasma. MATERIALS AND METHODS: After a two month wash-out, 13 volunteers were randomly assigned to either the patch followed by the oral contraceptive or vice versa, or the ring followed by the oral contraceptive or vice versa. All treatments lasted two cycles and were separated by a wash-out of two cycles. APC-sr and SHBG levels were determined on day 18-21 of the second cycle of the wash-out and of each treatment period. RESULTS: Compared to the oral contraceptive, both the patch and the ring led to higher APC resistance (mean difference APC-sr 1.1; 95% CI 0.67-1.52 and 0.55; 95% CI 0.11-1.00, respectively) and higher SHBG levels (mean difference 210 nmol/l; 95% CI 134-286 and 148 nmol/l; 95% CI 48-248, respectively). CONCLUSION: The activity of the protein C system in plasma was impaired more by contraceptive patch and vaginal ring than by an oral contraceptive containing the second generation progestagen levonorgestrel. Language: English Keywords: NETHERLANDS | RESEARCH REPORT | ETHINYL ESTRADIOL | VAGINAL RING | ORAL CONTRACEPTIVES | THROMBOSIS | RISK FACTORS | Europe, Western | Europe | Developed Countries | Contraceptive Agents, Estrogen | Contraceptive Agents, Female | Contraceptive Agents | Contraception | Family Planning | Contraceptive Methods | Thromboembolism | Embolism | Vascular Diseases | Diseases | Health Document Number: 330863 |
| 13. Peer Reviewed Title: Scheduled and unscheduled bleeding patterns with two combined hormonal contraceptives: application of new recommendations for standardization. Author: Hampton RM; Fisher AC; Pagano S; LaGuardia KD Source: Fertility and Sterility. 2009 Aug;92(2):434-40. Abstract: OBJECTIVE: To reassess and compare cycle control attained with two combined hormonal contraceptives, norgestimate (NGM)/ethinyl estradiol (EE) 25 microg and norethindrone acetate (NETA)/EE 20 microg, by new general criteria recommendations for all combined hormonal contraceptives. DESIGN: Analysis of bleeding data for cycles 1-6 from a randomized, multicenter trial. SETTING: 221 North American centers. PATIENT(S): Healthy, sexually active women (18-45 years old). INTERVENTION(S): NETA/EE: 1 mg NETA/20 microg EE, days 1-21 of each cycle and 75 mg of ferrous fumarate, days 22-28; NGM/EE: triphasic NGM in 7-day increments (days 1-7: 180 microg; days 8-14: 215 microg; days 15-21: 250 microg) and 25 microg EE, placebo on days 22-28. MAIN OUTCOME MEASURE(S): Cycle control evaluated from patients' daily diaries. RESULT(S): For cycles 1-6, there was a statistically significant lower incidence of unscheduled bleeding/spotting with NGM/EE 25 microg (range 21.0%-34.4%) than with NETA/EE 20 microg (range 33.0%-46.6%). Of the women who had unscheduled bleeding/spotting, the mean number of days per cycle of bleeding/spotting was comparable. A statistically significant higher incidence of scheduled bleeding was seen with NGM/EE 25 microg (95.2%-97.5%) than with NETA/EE 20 microg (78.5%-84.2%). CONCLUSION(S): The NGM/EE 25 microg has a lower incidence and comparable length of unscheduled bleeding and a higher incidence of scheduled bleeding than NETA/EE 20 microg in this post hoc analysis. Language: English Keywords: NORTH AMERICA | RESEARCH REPORT | CLINICAL TRIALS | ORAL CONTRACEPTIVES, COMBINED | ETHINYL ESTRADIOL | NORETHINDRONE ACETATE | BLEEDING | STANDARDS | EVALUATION | RECOMMENDATIONS | Developed Countries | Americas | Clinical Research | Research Methodology | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Contraceptive Agents, Estrogen | Contraceptive Agents, Female | Contraceptive Agents | Norethindrone | Contraceptive Agents, Progestin | Signs and Symptoms | Diseases Document Number: 342585 |
| 14. Title: Effect of administration of oral contraceptives in vivo on collagen synthesis in tendon and muscle connective tissue in young women. Author: Hansen M; Miller BF; Holm L; Doessing S; Petersen SG; Skovgaard D; Frystyk J; Flyvbjerg A; Koskinen S; Pingel J; Kjaer M; Langberg H Source: Journal of Applied Physiology. 2009 Apr;106(4):1435-43. Abstract: Women are at greater risk than men for certain kinds of diseases and injuries, which may at least partly be caused by sex hormonal differences. We aimed to test the influence of estradiol in vivo on collagen synthesis in tendon, bone, and muscle. Two groups of young, healthy women similar in age, body composition, and exercise-training status were included. The two groups were either habitual users of oral contraceptives exposed to a high concentration of synthetic estradiol and progestogens (OC, n = 11), or non-OC-users tested in the follicular phase of the menstrual cycle characterized by low concentrations of estradiol and progesterone (control, n = 12). Subjects performed 1 h of one-legged kicking exercise. The next day collagen fractional synthesis rates (FSR) in tendon and muscle connective tissue were measured after a flooding dose of [(13)C]proline followed by biopsies from the patellar tendon and vastus lateralis in both legs. Simultaneously, microdialysis catheters were inserted in vastus lateralis and in front of the patellar tendon for measurement of insulin-like growth factor I (IGF-I) and its binding proteins. Serum NH(2)-terminal propeptide of type I collagen (PINP) and urine COOH-terminal telopeptides of type-I collagen (CTX-I) were measured as markers for bone synthesis and breakdown, respectively. Tendon FSR and PINP were lower in OC compared with control. An increase in muscle collagen FSR postexercise was only observed in control (P < 0.05). Furthermore, the results indicate a lower bioavailability of IGF-I in OC. In conclusion, synthetic female sex hormones administered as OC had an inhibiting effect on collagen synthesis in tendon, bone, and muscle connective tissue, which may be related to a lower bioavailability of IGF-I. Language: English Keywords: DENMARK | RESEARCH REPORT | WOMEN | ESTROGENS | FITNESS | ETHINYL ESTRADIOL | SKELETAL EFFECTS | ORAL CONTRACEPTIVES | MUSCULAR EFFECTS | Developed Countries | Europe, Northern | Europe | Demographic Factors | Population | Hormones | Endocrine System | Physiology | Biology | Health | Contraceptive Agents, Estrogen | Contraceptive Agents, Female | Contraceptive Agents | Contraception | Family Planning | Contraceptive Methods Document Number: 341364 |
| 15. Peer Reviewed Title: Efficacy and safety of a low-dose combined oral contraceptive containing drospirenone 3 mg and ethinylestradiol 20 mcg in a 24/4-day regimen. Author: Hernadi L; Marr J; Trummer D; De Leo V; Petraglia F Source: Contraception. 2009 Jul;80(1):18-24. Abstract: OBJECTIVE: The study was conducted to assess the efficacy of a low-dose combined oral contraceptive (COC) containing drospirenone (drsp) 3 mg/ethinylestradiol (EE) 20 mcg administered for 24 days of active treatment followed by a 4-day hormone-free interval (24/4 regimen). STUDY DESIGN: In this open-label uncontrolled study conducted in 50 European centers, healthy females aged 18-35 years with a body mass index of less than 30 kg/m(2) received drsp 3 mg/EE 20 mcg 24/4 over 13 cycles. The primary efficacy variable was the number of unintended pregnancies. RESULTS: Five pregnancies occurred among 1101 women over 13,248 treatment cycles, resulting in a Pearl Index (PI) of 0.49 with an upper two-sided 95% CI limit of 1.14. Of these pregnancies, three were attributed to noncompliance with tablet use resulting in an adjusted PI for 'perfect use' of 0.22 (upper limit of two-sided 95% CI: 0.80) based on 11,755 cycles. CONCLUSION: Drospirenone 3 mg/EE 20 mcg 24/4 is a highly effective COC in nonobese women. Language: English Keywords: EUROPE | RESEARCH REPORT | CLINICAL TRIALS | PEARL'S FORMULA | WOMEN | CONTRACEPTIVE EFFECTIVENESS | ORAL CONTRACEPTIVES, LOW-DOSE | ORAL CONTRACEPTIVES, COMBINED | ETHINYL ESTRADIOL | CONTRACEPTIVE SAFETY | Developed Countries | Clinical Research | Research Methodology | Contraceptive Use-Effectiveness | Contraception | Family Planning | Demographic Factors | Population | Oral Contraceptives | Contraceptive Methods | Contraceptive Agents, Estrogen | Contraceptive Agents, Female | Contraceptive Agents | Safety | Public Health | Health Document Number: 341586 |
| 16. Peer Reviewed Title: Cyproterone acetate- and ethinyloestradiol-containing oral contraceptive as a risk factor for upper extremity deep venous thrombosis-a case report. Author: Kapur R; Stramrood CA; Schutgens RE; van Asbeck BS Source: European Journal of Contraception and Reproductive Health Care. 2009 Apr;14(2):160-3. Abstract: Deep venous thrombosis of the upper extremity (UEDVT) is a rare variety of deep venous thrombosis. Compared to lower-extremity deep venous thrombosis, less is known about the risk factors for primary UEDVT. We report on a 27-year-old woman with UEDVT extending from the jugular and subclavian veins to the elbow. The thrombosis was possibly provoked by a shoulder trauma, in combination with heterozygosity for the prothrombin G20210A mutation and a protein S-deficiency, which may have been induced by the use of a cyproterone acetate- and ethinyloestradiol (CPA/EE)-containing oral contraceptive. Language: English Keywords: NETHERLANDS | RESEARCH REPORT | CLINICAL RESEARCH | CASE STUDIES | WOMEN | ETHINYL ESTRADIOL | ORAL CONTRACEPTIVES, COMBINED | THROMBOSIS | ACCIDENTS AND INJURIES | CHROMOSOME ABNORMALITIES | CYPROTERONE ACETATE | ORAL CONTRACEPTIVES, SIDE EFFECTS | CONTRACEPTIVE SAFETY | Europe, Western | Europe | Developed Countries | Research Methodology | Studies | Demographic Factors | Population | Contraceptive Agents, Estrogen | Contraceptive Agents, Female | Contraceptive Agents | Contraception | Family Planning | Oral Contraceptives | Contraceptive Methods | Thromboembolism | Embolism | Vascular Diseases | Diseases | Health | Neonatal Diseases and Abnormalities | Hormone Antagonists | Hormones | Endocrine System | Physiology | Biology | Safety | Public Health Document Number: 330935 |
| 17. Title: [The impact of a new low dose oral contraceptive containing drospirenone on lipid profile, carbohydrate metabolism and hepatic function] Wplyw stosowania nowej, nisko-estrogenowej tabletki antykoncepcyjnej zawierajcej Author: Katarzyna SS; Stanislaw R; Katarzyna S Source: Ginekologia Polska. 2009 Feb;80(2):99-102. Abstract: INTRODUCTION: Application of older generations of progestins used in oral contraceptives may increase the risk of cardiovascular diseases (CVD) because of negative impact on lipids parameters. Drospirenone is a unique progestin that blocks the aldosterone receptor, demonstrates antiandrogenic activity and potentially decreases the risk of CVD. OBJECTIVES: The aim of the study was to estimate the impact of low dose oral contraceptive containing 20 microg ethinyloestradiol and 3.0 mg drospirenone on lipid parameters, carbohydrate metabolism and hepatic function. MATERIAL AND METHODS: 22 women in mean age 25.9 +/- 4.3 years, mean BMI (body mass index) 21.9 +/- 2.3 kg/m2 without contraindication to hormonal contraception using tablets containing 20 microg ethinylestradiol and 3.0 mg drospirenone during 12 cycles. Total cholesterol (CHOL), high-density lipoprotein cholesterol (HDL), low-density lipoprotein cholesterol (LDL), triglycerides (TG), glucose (GLU) and hepatic parameters were assessed before and after 3, 6 and 12 cycles of the treatment using enzymatic methods. RESULTS: We observed statistically significant increase of CHOL level in normal ranges from 172.4 +/- 22.5 mg/dl before treatment to 185.6 +/- 25.3 mg/dl after 12 cycles and HDL level from 63.7 +/- 10.8 mg/dl to 70.6 +/- 14.4 mg/dl. No statistically significant differences were observed in LDL and TG concentrations, glycaemia and hepatic function parameters after 12 cycles of the therapy. CONCLUSION: The treatment with new low dose oral contraceptive containing 20 microg ethinylestradiol and 3.0 mg drospirenone does not induce adverse changes in lipids parameters and hepatic function. Language: Polish Keywords: RESEARCH REPORT | WOMEN | CONTRACEPTIVE USAGE | ORAL CONTRACEPTIVES | ORAL CONTRACEPTIVES, LOW-DOSE | ETHINYL ESTRADIOL | CONTRACEPTIVE USE-EFFECTIVENESS | IMPACT | Demographic Factors | Population | Contraception | Family Planning | Contraceptive Methods | Contraceptive Agents, Estrogen | Contraceptive Agents, Female | Contraceptive Agents | Contraceptive Effectiveness | Communication Document Number: 330929 |
| 18. Title: Lack of effect of tenofovir disoproxil fumarate on pharmacokinetics of hormonal contraceptives. Author: Kearney BP; Mathias A Source: Pharmacotherapy. 2009 Aug;29(8):924-9. Abstract: STUDY OBJECTIVE: To assess the potential for a drug-drug interaction between a representative hormonal contraceptive (norgestimate-ethinyl estradiol) and tenofovir disoproxil fumarate (tenofovir DF), a prodrug of tenofovir, when coadministered. DESIGN: Thirty-day, open-label, fixed-sequence, pharmacokinetic drug-drug interaction study. SETTING: Single clinical phase I center. PARTICIPANTS: Twenty nonpregnant and nonlactating women aged 19-45 years who were taking a norgestimate-ethinyl estradiol oral contraceptive. INTERVENTION: Each woman received norgestimate-ethinyl estradiol alone on study days 1-22, followed by norgestimate-ethinyl estradiol plus tenofovir DF 300 mg once/day for 7 days during two consecutive 28-day contraceptive cycles. MEASUREMENTS AND MAIN RESULTS: Pharmacokinetic assessments were performed over 24 hours on study days 1 and 29 (corresponding to matching days [day 21] of the two contraceptive cycles). Serum or plasma concentrations of tenofovir, norgestimate and its active metabolite deacetyl norgestimate, and ethinyl estradiol were measured by high-performance liquid chromatography-tandem mass spectrometry assays. Geometric mean ratios (90% confidence intervals) for the pharmacokinetic parameters for deacetyl norgestimate and ethinyl estradiol were estimated by using analysis of variance and compared with the no-effect criterion for bioequivalence. The tenofovir pharmacokinetic parameters were compared with historical controls. Pharmacokinetic parameters for deacetyl norgestimate and ethinyl estradiol were unaltered by coadministration of tenofovir DF. The tenofovir pharmacokinetic parameters in subjects receiving norgestimate-ethinyl estradiol were consistent with historical control data for tenofovir. CONCLUSION: Tenofovir DF and norgestimate-ethinyl estradiol are not involved in a clinically significant drug-drug interaction; tenofovir DF did not affect the steady-state pharmacokinetics of norgestimate or ethinyl estradiol, including the concentration at the end of the dosing interval. Both drugs were well tolerated when coadministered. Tenofovir DF is unlikely to affect the pharmacokinetics of hormonal oral contraceptives. Language: English Keywords: UNITED STATES OF AMERICA | RESEARCH REPORT | CLINICAL TRIALS | WOMEN | ORAL CONTRACEPTIVES, COMBINED | NORGESTIMATE | ETHINYL ESTRADIOL | ANTIRETROVIRAL DRUGS | ADMINISTRATION AND DOSAGE | DRUG INTERACTIONS | SIDE EFFECTS | Developed Countries | North America | Americas | Clinical Research | Research Methodology | Demographic Factors | Population | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Contraceptive Agents, Progestin | Contraceptive Agents, Female | Contraceptive Agents | Contraceptive Agents, Estrogen | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Drugs Document Number: 342300 |
| 19. Peer Reviewed Title: Oral contraception usage in relation to bone mineral density and bone turnover in adolescent girls. Author: Lattakova M; Borovsky M; Payer J; Killinger Z Source: European Journal of Contraception and Reproductive Health Care. 2009 Jun;14(3):207-14. Abstract: OBJECTIVES: To compare the effect of a low-dose oral contraceptive (OC) containing 30 microg ethinyloestradiol (EE) with that of an ultra-low-dose OC containing 15 microg EE on bone turnover and BMD in healthy adolescent women and, in addition, to ascertain the influence of body mass index (BMI) and exercise on these indices of bone metabolism. METHODS: We recruited to the study 92 healthy girls aged between 16 and 19. They were divided into three groups. Participants in the first two groups used an OC with either 15 or 30 microg ethinyloestradiol (EE), whereas those in the third group used no hormonal contraception. Bone mineral density (BMD) and bone turnover markers were measured before and after 12 months of treatment. RESULTS: The BMD values of the total hip in females using the OC containing 30 microg EE was 0.912 g/cm(2) at baseline and 0.918 g/cm(2) after one year; in females using the OC containing 15 microg EE the corresponding values were 0.888 g/cm(2) and 0.895 g/cm(2) whereas in females who used no contraception BMD values were 0.942 g/cm(2) and 0.949 g/cm(2), respectively. The changes were statistically insignificant. Levels of osteocalcin and CTX had decreased after one year in all groups, but not statistically significantly so. CONCLUSION: Low dose and ultra-low dose oral contraceptives did not significantly differ in their effects on bone mineral density or bone turnover markers in adolescent girls aged 16-19. Language: English Keywords: SLOVAKIA | RESEARCH REPORT | CONTROL GROUPS | ADOLESCENTS, FEMALE | ORAL CONTRACEPTIVES, LOW-DOSE | ADMINISTRATION AND DOSAGE | SKELETAL EFFECTS | ETHINYL ESTRADIOL | BODY WEIGHT | FITNESS | Developing Countries | Europe, Central | Europe | Research Methodology | Adolescents | Youth | Age Factors | Population Characteristics | Demographic Factors | Population | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Physiology | Biology | Contraceptive Agents, Estrogen | Contraceptive Agents, Female | Contraceptive Agents Document Number: 341800 |
| 20. Title: Comparison of the content, uniformity of dosage units and dissolution rate of triphasic oral contraceptives from two pharmaceutical factories. Author: Liu H; Li Y; Liu JP Source: Journal of Reproduction and Contraception. 2009 Jun;20(2):123-129. Abstract: Objective: To compare the content, uniformity of dosage units and dissolution rate of triphasic oral contraceptives from two pharmaceutical factories A and B. Methods: A High Performance Liquid Chromatography (HPLC) method for the simultaneous determination of levonorgestrel and ethinylestradiol was used. The content of levonorgestrel (LNG) was monitored by an UV detector at 247nm, while ethinylestradiol (EE) was monitored by fluorescence detector with the excitation of 285 nm and emission wavelengths of 310 nm. The dissolution test was performed using the paddle method. Results The content of levongestrel (LNG) and ethinylestradiol (EE) in product A was within 100.5%-122.4% while product B within 120.6%-140.9%. The uniformity value of dosage units of tablets from two factories was more than 15. The dissolution rate of tables from two factories was more than 60% within 60 min. Conclusion Only the content of product A was in the ±25% range of label claim. The uniformity of two products was not up to standard. The dissolution rate of the tablets from two products met the requirement of ChP2005. Language: English Keywords: CHINA | RESEARCH REPORT | COMPARATIVE STUDIES | LABORATORY PROCEDURES | LEVONORGESTREL | ETHINYL ESTRADIOL | ORAL CONTRACEPTIVES | ADMINISTRATION AND DOSAGE | Asia, Eastern | Asia | Developing Countries | Studies | Research Methodology | Laboratory Examinations and Diagnoses | Examinations and Diagnoses | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Contraceptive Agents, Progestin | Contraceptive Agents, Female | Contraceptive Agents | Contraception | Family Planning | Contraceptive Agents, Estrogen | Contraceptive Methods | Drugs | Treatment Document Number: 339904 |
| 21. Title: Emergency contraception: Knowledge, attitude and prescription practice among doctors in different specialties in Hong Kong. Author: Lo SS; Kok WM; Fan SY Source: Journal of Obstetrics and Gynaecology Research. 2009 Aug;35(4):767-74. Abstract: Aim: Few studies have evaluated doctors' knowledge, attitudes and practices as regards emergency contraception (EC). Some studies have reported inadequate knowledge, bias and wrong prescriptions by doctors. This article compares the prescription pattern, attitude and knowledge of EC in Hong Kong doctors in different specialties. Methods: Questionnaires were mailed to family physicians, obstetrician-gynecologists and doctors working in family planning clinics to ascertain their attitudes to EC. Those who provided EC described the types of EC used, whether drugs were given in advance and answered a 12-question knowledge test. Those who did not provide EC stated why. Results: A total of 443 completed questionnaires were analyzed: 70.9% of doctors agreed that the benefits of EC outweigh its risks and 61.2% agreed that doctors should discuss it with clients. Advanced provision was supported by 54.2% of doctors but reduced to 32.5% if the target client was a girl aged 16 or below. Even fewer doctors (40.2%) supported the over-the-counter sales of EC pills. In the knowledge test, family planning doctors scored 10.45 out of 12 and obstetrician-gynecologists in private practice had the lowest score of 6.08. Family planning doctors used levonorgestrel pills while private family physicians and obstetrician-gynecologists used Yuzpe. Among 352 doctors who provided EC, only 21.7% of private family physicians and 15.9% of private obstetrician-gynecologists prescribed it in advance. Conclusions: Only doctors working in family planning clinics were competent in their knowledge of emergency contraception and up to date with current practice. Although half of the doctors supported advanced provision, few implemented it. Most doctors did not support advanced provision to young girls nor the over-the-counter sales of EC pills. Language: English Keywords: HONG KONG | RESEARCH REPORT | KAP SURVEYS | PHYSICIANS | EMERGENCY CONTRACEPTION | PRESCRIPTIONS | CONTRACEPTIVE DISTRIBUTION | OBSTACLES | LEVONORGESTREL | ETHINYL ESTRADIOL | IUD | QUESTIONNAIRES | AGE FACTORS | Developed Countries | Asia, Eastern | Asia | Surveys | Sampling Studies | Studies | Research Methodology | Health Personnel | Delivery of Health Care | Health | Contraception | Family Planning | Distributional Activities | Program Activities | Programs | Organization and Administration | Contraceptive Agents, Progestin | Contraceptive Agents, Female | Contraceptive Agents | Contraceptive Agents, Estrogen | Contraceptive Methods | Population Characteristics | Demographic Factors | Population Document Number: 342776 |
| 22. Peer Reviewed Title: Effects of an antiandrogenic oral contraceptive pill compared with metformin on blood coagulation tests and endothelial function in women with the polycystic ovary syndrome: influence of obesity and smoking. Author: Luque-Ramirez M; Mendieta-Azcona C; Del Rey J; Maties M; Escobar-Morreale H Source: European Journal of Endocrinology. 2009;160:469-480. Abstract: Objective: To study the blood clotting tests and endothelial function of PCOS patients and non-hyperandrogenic women, and their changes during PCOS treatment, as a function of the presence of obesity and smoking. Design: Case-control study followed by a randomized clinical trial. Methods: Blood clotting and endothelial function were analyzed in 40 PCOS patients and 20 non-hyperandrogenic women. 34 PCOS women were randomized to Diane35Diario or metformin (850 mg twice daily), monitoring the changes on these parameters during 24 weeks of treatment. The influence of obesity and smoking was also analyzed. Results: Blood clotting and endothelial function tests were similar among PCOS patients and controls with the exception of a higher platelet count in the former. Obesity increased circulating fibrinogen levels, prothrombin activity and platelet counts, and reduced prothrombin and activated partial thromboplastin times. Smoking increased fibrinogen levels, platelet counts and prothrombin activity, andreduced prothrombin time, in relation to the larger waist circumference of smokers. Irrespective of the treatment received, PCOS patients showed a decrease in prothrombin time and an increase in prothrombin activity, with a parallel increase in homocysteine levels with metformin. The activated partial thromboplastin time decreased markedly with Diane35Diario. Finally, flow-mediated dilation improved in non-smokers irrespective of the drug, but worsened in smokers. Conclusions: Oral contraceptives and metformin may exert deleterious effects on blood clotting tests of PCOS women, yet the effects of metformin appear to be milder. Because smoking potentiates some of these effects and deteriorates endothelial function, smoking cessation should be promoted in PCOS patients. Language: English Keywords: SPAIN | RESEARCH REPORT | CLINICAL TRIALS | WOMEN | CLIENTS | BLOOD | HEMATOLOGIC TESTS | ORAL CONTRACEPTIVES | ETHINYL ESTRADIOL | OBESITY | BODY WEIGHT | TOBACCO USE | Europe, Southwestern | Europe | Developed Countries | Clinical Research | Research Methodology | Demographic Factors | Population | Program Activities | Programs | Organization and Administration | Hemic System | Physiology | Biology | Laboratory Procedures | Laboratory Examinations and Diagnoses | Examinations and Diagnoses | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Contraceptive Methods | Contraception | Family Planning | Contraceptive Agents, Estrogen | Contraceptive Agents, Female | Contraceptive Agents | Behavior Document Number: 329669 |
| 23. Title: Activation of NF-kappaB and COX-2 expression is associated with breakthrough bleeding in patients using oral contraceptives in extended regimens. Author: Maia H Jr; Casoy J; Correia T; Athayde C; Valente J; Coutinho EM Source: Gynecological Endocrinology. 2009 Sep 11;:1-5. Abstract: The objective of the present study was to determine whether there is an increase in endometrial inflammation associated with the occurrence of breakthrough bleeding in patients using an oral contraceptive in extended regimens. The presence of nuclear factor NF-kappaB and Cox-2 expression was determined by immunohistochemistry in endometrial samples removed by hysteroscopy from patients with breakthrough bleeding during continuous use of an oral contraceptive containing gestodene. All patients had a history of menorrhagia associated or not with the presence of uterine pathology. The percentage of endometria showing a positive staining reaction for NF-kappaB in cell nuclei was significantly higher in patients with breakthrough bleeding than in those with amenorrhea. Cox-2 expression in the endometrium was also significantly more frequent in patients with breakthrough bleeding. The occurrence of breakthrough bleeding in patients with uterine pathology using combined oral contraceptives is associated with the activation of endometrial inflammation through the NF-kappaB pathway. Language: English Keywords: BRAZIL | RESEARCH REPORT | CLIENTS | ORAL CONTRACEPTIVES, COMBINED | ENDOMETRIAL EFFECTS | MENORRHAGIA | ETHINYL ESTRADIOL | GESTODENE | AMENORRHEA | HISTOLOGY | South America, Eastern | South America | Latin America | Americas | Developing Countries | Program Activities | Programs | Organization and Administration | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Endometrium | Uterus | Genitalia, Female | Genitalia | Urogenital System | Physiology | Biology | Menstruation Disorders | Diseases | Contraceptive Agents, Estrogen | Contraceptive Agents, Female | Contraceptive Agents | Contraceptive Agents, Progestin Document Number: 342842 |
| 24. Title: A randomized controlled trial of a low-dose combined oral contraceptive containing 3 mg drospirenone plus 20 microg ethinylestradiol in the treatment of acne vulgaris: lesion counts, investigator ratings and subject self-assessment. Author: Maloney JM; Dietze P Jr; Watson D; Niknian M; Lee-Rugh S; Sampson-Landers C; Korner P Source: Journal of Drugs In Dermatology. 2009 Sep;8(9):837-44. Abstract: OBJECTIVE: To assess the efficacy of a combined oral contraceptive (COC) containing 3 mg drospirenone (drsp) plus 20 microg ethinylestradiol (EE) administered in 24 days of active treatment followed by a four-day hormone-free interval (24/4 regimen) compared with placebo for the treatment of moderate acne vulgaris. METHODS: Healthy females (14-45 years old) with moderate facial acne were randomized to 3 mg drsp/20 microg EE 24/4 (n = 270) or placebo (n = 268) for six cycles. The secondary efficacy variables measured included change from baseline to endpoint (cycle 6) in individual lesion count for nodules, papules, pustules, open and closed comedones. RESULTS: There were significantly greater reductions in individual lesion counts from baseline to endpoint in the 3 mg drsp/20 microg EE group than in the placebo group (P < 0.05 from parametric model). CONCLUSION: The 3 mg drsp/20 microg EE COC administered in a 24/4 regimen significantly reduced acne lesions. Language: English Keywords: UNITED STATES OF AMERICA | RESEARCH REPORT | CONTROL GROUPS | CLIENTS | WOMEN | ORAL CONTRACEPTIVES, COMBINED | LOW-DOSE PROGESTINS | ETHINYL ESTRADIOL | ACNE | TREATMENT | DERMATOLOGICAL EFFECTS | Developed Countries | North America | Americas | Research Methodology | Program Activities | Programs | Organization and Administration | Demographic Factors | Population | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Contraceptive Agents, Progestin | Contraceptive Agents, Female | Contraceptive Agents | Contraceptive Agents, Estrogen | Dermatitis | Diseases | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Physiology | Biology Document Number: 342779 |
| 25. Title: Comparative performance of a combined injectable contraceptive (50 mg norethisterone enanthate plus 5mg estradiol valerate) and a combined oral contraceptive (0.15 mg levonorgestrel plus 0.03 mg ethinyl estradiol) in adolescents. Author: Molina RC; Sandoval JZ; Montero AV; Oyarzun PG; Molina TG; Gonzalez EA Source: Journal of Pediatric and Adolescent Gynecology. 2009 Feb;22(1):25-31. Abstract: STUDY OBJECTIVE: To compare in a regular non-clinical trial experience the efficacy, acceptability, and continuation rates of an injectable contraceptive containing 50 mg norethisterone enanthate plus 5mg estradiol valerate (IC) and an oral contraceptive containing 0.15 mg levonorgestrel plus 0.03 mg ethinyl estradiol (OC), among adolescent users. DESIGN: A total of 251 adolescents ages 14-19 were followed during 12 months. The IC group (124 subjects) was studied for 1044 cycles and the OC group (127 subjects) was studied for 1368 cycles. The users were not assigned in a random selection. Information was collected from clinical records. Groups were compared using Pearson chi-square, odds ratio (95% confidence interval), t-test, and proportion difference test. RESULTS: The IC group had significant differences in baseline social risk, confidence, psychiatric problems, consumption of alcohol, and number of sexual partners. At 12 months, the IC group showed significant decrease in weight and increase in hypermenorrhea. In the OC group, dysmenorrhea decreased, and hypomenorrhea and regular cycles were significantly more frequent. One pregnancy occurred in the OC group (Pearl Index: 0.88). Final continuation rates at 12 months were 41.9% and 37.8% for IC and OC, respectively. CONCLUSIONS: The monthly injectable is a recommended contraceptive option for adolescents, especially for those facing psychosocial risk factors. Language: English Keywords: CHILE | RESEARCH REPORT | CLINICAL RESEARCH | COMPARATIVE STUDIES | ADOLESCENTS, FEMALE | INJECTABLES | NORETHINDRONE ENANTHATE | ORAL CONTRACEPTIVES, COMBINED | LEVONORGESTREL | ETHINYL ESTRADIOL | ADMINISTRATION AND DOSAGE | TIME FACTORS | CONTRACEPTIVE EFFECTIVENESS | CONTRACEPTIVE SAFETY | Developing Countries | South America, Southern | South America | Latin America | Americas | Research Methodology | Studies | Adolescents | Youth | Age Factors | Population Characteristics | Demographic Factors | Population | Contraceptive Methods | Contraception | Family Planning | Norethindrone | Contraceptive Agents, Progestin | Contraceptive Agents, Female | Contraceptive Agents | Oral Contraceptives | Contraceptive Agents, Estrogen | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Population Dynamics | Safety | Public Health Document Number: 330349 |
| 27. Peer Reviewed Title: Efficacy of a combined oral contraceptive containing 0.030 mg ethinylestradiol/2 mg dienogest for the treatment of papulopustular acne in comparison with placebo and 0.035 mg ethinylestradiol/2 mg cyproterone acetate. Author: Palombo-Kinne E; Schellschmidt I; Schumacher U; Graser T Source: Contraception. 2009 Apr;79(4):282-9. Abstract: BACKGROUND: Acne is a multifactorial disease characterized by androgenic stimulation of sebaceous glands. Therefore, combined oral contraceptives (COCs) containing anti-androgenic progestogens are suitable candidates for acne treatment. This study aimed to show that a COC containing the anti-androgen dienogest (DNG) is superior to placebo and not inferior to a COC containing the potent anti-androgen cyproterone acetate (CPA) in improving mild to moderate acne. STUDY DESIGN: Healthy women between 16 and 45 years old with mild to moderate facial acne were randomly assigned to receive ethinylestradiol (EE)/DNG (n=525), EE/CPA (n=537) or placebo (n=264) for six cycles in a multinational, multicenter, three-arm, double-blind and randomized trial. The primary efficacy variables were the percentages of change (from baseline to cycle 6) in inflammatory and total lesion count and the percentage of patients with acne improvement according to the Investigator Global Assessment. RESULTS: All primary analyses proved that EE/DNG was superior to placebo and non-inferior to EE/CPA (p<.05). For inflammatory lesions, the reduction (+/-SD) rates were -65.6+/-29.9% for EE/DNG, -64.6+/-31.2% for EE/CPA and -49.4+/-41.0% for placebo. For total lesions, the reduction rates were -54.7+/-26.3% for EE/DNG, -53.6+/-27.5% for EE/CPA and -39.4+/-33.6% for placebo. The percentages of patients with improvement of facial acne were 91.9% for EE/DNG, 90.2% for EE/CPA and 76.2% for placebo. CONCLUSION: EE/DNG was superior to placebo, in spite of the prominent placebo effects, and as effective as EE/CPA in the treatment of mild to moderate acne, thus proving a valid option for the treatment of acne in women seeking oral contraception. Language: English Keywords: GERMANY | RESEARCH REPORT | CLINICAL TRIALS | WOMEN | ACNE | ORAL CONTRACEPTIVES | ETHINYL ESTRADIOL | TREATMENT | Europe, Central | Europe | Developed Countries | Clinical Research | Research Methodology | Demographic Factors | Population | Dermatitis | Diseases | Contraceptive Methods | Contraception | Family Planning | Contraceptive Agents, Estrogen | Contraceptive Agents, Female | Contraceptive Agents | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health Document Number: 330559 |
| 28. Title: Confronting the legal risks of prescribing the contraceptive patch with ongoing litigation [letter] Author: Patsner B Source: Obstetrics and Gynecology. 2009 Jun;113(6):1367. Abstract: The valuable commentary by Drs. Phelps and Kelver on potential liability issues for physicians prescribing the Ortho-Evra (norelgestromin/ethinyl estradiol [E2]), Ortho Women's Health & Urology, Raritan, NJ) contraceptive patch1 provides a much-needed start, but only one perspective, on this important and ongoing clinical practice issue. As a food and drug law attorney as well as a former Senior Medical Officer in the Division at the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration (FDA), which handled the original approval of the contraceptive patch as well the ensuing controversy, I would like to provide additional information and a different perspective. None of the major verdicts on the contraceptive patch litigation are in yet. There is likely to be more information, some potentially negative, forthcoming on both FDA and sponsor conduct. There was a great deal of controversy within the FDA itself over whether the controversy was handled correctly, whether the original new drug application should have been approved, how the original data and the data corrections on pharmacokinetics and adverse events were reviewed and rereviewed, whether there was an attempt at "information control" of either FDA errors or unfavorable information about the product, and significant internal disagreements over the general lack of timely cooperation by the FDA with organizations such as the American College of Obstetricians and Gynecologists when the latter urgently requested guidance for its member physicians. The two studies quoted by the authors clearly do not provide a sufficient basis for their claim that "the transdermal patch may be the best choice for many patients who prefer the convenience of a weekly patch." Citing the higher incidence of venous thromboembolism in pregnancy as a possible defense to claims concerning the incidence for the contraceptive patch is largely irrelevant because the comparison in any malpractice action will be with oral contraceptives, not pregnancy.Physicians should be aware that even the best informed consent likely will provide little or no shield if they are sued in a medical malpractice action for prescribing the patch and that significant safety concerns remain for this product, particularly because it has been difficult to predict which women are at greatest risk for early embolic events. Absent an overwhelming reason for prescribing the contraceptive patch, I personally think ob-gyns should steer clear of the product. More importantly, it would have been more instructive for the authors to go to the original new drug application itself (readily accessed although the Center for Drug Evaluation and Research Web site at www.cder.fda.gov) to discuss the original safety data as well as why the approval decision was made, rather than just citing the labeling update or an FDA "Talk Paper." Even a cursory perusal of the original new drug application2 reveals many pages discussing concerns about the potentially higher risk of venous thromboembolism for this product. Because there are no firm FDA "rules" for determining the outcome of the risk-benefit calculus for any new prescription drug product, and because the patch not only did not work "better" than existing oral contraceptives but also had a potentially greater risk, the justification for approving the product was largely because it was a novel delivery system. The fact is that the FDA can and does approve new drug products that are less effective or more dangerous than existing drug products already on the market. All practicing physicians should be aware of this. When drug safety is less of an FDA priority than getting new products to market (as was the case under the Bush administration), the risks to patients will be greater. When the FDA does its job poorly, regulation of big pharma depressingly comes down to the plaintiffs' bar. (full-text) Language: English Keywords: UNITED STATES OF AMERICA | TEXAS | CRITIQUE | USFDA | PRESCRIPTIONS | ETHINYL ESTRADIOL | DRUGS | CONTRACEPTION | PRODUCT APPROVAL | Developed Countries | North America | Americas | USPHS | Government Agencies | Organizations | Political Factors | Sociocultural Factors | Distributional Activities | Program Activities | Programs | Organization and Administration | Contraceptive Agents, Estrogen | Contraceptive Agents, Female | Contraceptive Agents | Family Planning | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Legislation Document Number: 341194 |
| 29. Peer Reviewed Title: Efficacy of an oral contraceptive containing EE 0.03 mg and CMA 2 mg (Belara) in moderate acne resolution: a randomized, double-blind, placebo-controlled Phase III trial. Author: Plewig G; Cunliffe WJ; Binder N; Hoschen K Source: Contraception. 2009 Jul;80(1):25-33. Abstract: BACKGROUND: The study was conducted to assess the effects of the monophasic combined oral contraceptive containing ethinyl estradiol (EE) 0.03 mg and chlormadinone acetate (CMA) 2 mg (EE/CMA) on papulopustular acne of the face, decollete (low neck) and back; on moderate comedonal acne of the face; and on seborrhea, alopecia and hirsutism. STUDY DESIGN: Three hundred seventy-seven women were randomized (2:1) to receive EE/CMA (n=251) or placebo (n=126) for six medication cycles. Due to the placebo-controlled, double-blind design of the trial, condoms were supplied for contraception. The primary efficacy end point was defined as a reduction of at least 50% in the number of papules and/or pustules of the face from admission to Medication Cycle 6. RESULTS: In total, 64.1% (161/251) of subjects treated with EE/CMA responded compared with 43.7% (55/126) of those taking placebo (p=.0001). The median reduction in papules/pustules on the face at Cycle 6 compared with admission was 63.6% (EE/CMA) compared with 45.3% (placebo group). For comedonal lesions of the face, the reduction in lesion numbers was 54.8% (EE/CMA) compared with 32.4% (placebo). Moderate papulopustular acne of the decollete decreased by 92.9% (EE/CMA) vs. 50% (placebo group) and of the back by 86.0% and 58.3%, respectively. For these skin conditions, the p values for the relative difference between groups vs. baseline were <.05 at Cycles 3 and 6, in favor of EE/CMA. As part of a self-assessment rating, at least 70.5% (EE/CMA) vs. 41.3% (placebo) reported an at least satisfactory improvement of their moderate acne. Even 39.8% of women taking EE/CMA reported an "excellent improvement" or "complete resolution" of moderate acne compared with 12.7% taking placebo. CONCLUSION: In addition to its contraceptive efficacy described elsewhere, EE/CMA is an effective treatment for moderate papulopustular acne and other androgen-related skin disorders. Language: English Keywords: UNITED KINGDOM | RESEARCH REPORT | RANDOMIZED RESPONSE TECHNIC | WOMEN | ORAL CONTRACEPTIVES, COMBINED | ETHINYL ESTRADIOL | ACNE | HIRSUTISM | TREATMENT | PROGRAM EFFECTIVENESS | Developed Countries | Europe, Western | Europe | Questionnaire Design | Survey Methodology | Surveys | Sampling Studies | Studies | Research Methodology | Demographic Factors | Population | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Contraceptive Agents, Estrogen | Contraceptive Agents, Female | Contraceptive Agents | Dermatitis | Diseases | Signs and Symptoms | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Program Evaluation | Programs | |