1.  Title: Headache induced by the use of combined oral contraceptives. Author: Allais G; Gabellari IC; Airola G; Borgogno P; Schiapparelli P; Benedetto C Source: Neurological Sciences. 2009 May;30 Suppl 1:S15-7. Abstract: Although combined oral contraceptives (COCs) are a safe and highly effective method of birth control, they may also give rise to problems of clinical tolerability in migraine patients. Indeed, headache is among the most common side effects reported with the use of COCs, frequently leading to their being discontinued. The latest International Classification of Headache Disorders identified at least two entities evidently related to the use of COCs, i.e., exogenous hormone-induced headache and estrogen-withdrawal headache. As to the former, the newest formulations of COCs are generally well tolerated by migraine without aura patients, but can worsen headache in migraine with aura patients. Headache associated with COCs, generally, tends to improve as their use continues. However, although it is not yet clear if there is an association between headache and the composition of COCs (both in the type and amount of hormones), it has been observed that the incidence of headache during COC use seems greater if migraine is associated with menstrual trigger. The estrogen-withdrawal headache is a headache that generally appears within the first 5 days after cessation of estrogen use and resolves within 3 days, even if in some cases it may appear on the sixth or seventh day after pill suspension and lasts more than 3 days. Language: English Keywords: ITALY | LITERATURE REVIEW | ORAL CONTRACEPTIVES, COMBINED | ORAL CONTRACEPTIVES, SIDE EFFECTS | HEADACHE | MIGRAINE | INCIDENCE | HORMONES | ESTROGENS | Developed Countries | Europe, Southern | Europe | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Contraceptive Safety | Safety | Public Health | Health | Signs and Symptoms | Diseases | Vascular Diseases | Measurement | Research Methodology | Endocrine System | Physiology | Biology Document Number: 342617 |
| 2. Title: Oral contraceptives in migraine. Author: Allais G; Gabellari IC; De Lorenzo C; Mana O; Benedetto C Source: Expert Review of Neurotherapeutics. 2009 Mar;9(3):381-93. Abstract: Combined oral contraceptives are a safe and highly effective method of birth control, but they can also raise problems of clinical tolerability and/or safety in migraine patients. It is now commonly accepted that, in migraine with aura, the use of combined oral contraceptives is always contraindicated, and that their intake must also be suspended by patients suffering from migraine without aura if aura symptoms appear. The newest combined oral contraceptive formulations are generally well tolerated in migraine without aura, and the majority of migraine without aura sufferers do not show any problems with their use; nevertheless, the last International Classification of Headache Disorders identifies at least two entities evidently related to the use of combined oral contraceptives: exogenous hormone-induced headache and estrogen-withdrawal headache. As regards the safety, even if both migraine and combined oral contraceptive intake are associated with an increased risk of ischemic stroke, migraine without aura per se is not a contraindication for combined oral contraceptive use. Other risk factors (tobacco use, hypertension, hyperlipidemia, obesity and diabetes) must be carefully considered when prescribing combined oral contraceptives in migraine without aura patients, in particular in women aged over 35 years. Furthermore, the exclusion of a hereditary thrombophilia and of alterations of coagulative parameters should precede any decision of combined oral contraceptive prescription in migraine patients. Language: English Keywords: ITALY | RESEARCH REPORT | CLIENTS | WOMEN | MIGRAINE | ORAL CONTRACEPTIVES, COMBINED | CONTRACEPTIVE SAFETY | CONTRACEPTIVE USE-EFFECTIVENESS | Developed Countries | Europe, Southern | Europe | Program Activities | Programs | Organization and Administration | Demographic Factors | Population | Vascular Diseases | Diseases | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Safety | Public Health | Health | Contraceptive Effectiveness Document Number: 330561 |
| 3. Title: Catching up on contraception. Author: Allen K Source: Australian Family Physician. 2009 Jun;38(6):380-2. Abstract: BACKGROUND: Providing contraceptive advice is a core activity in general practice. There have been numerous changes to the contraceptive options available in Australia over the past 10 years. It is important that general practitioners are aware of these changes so that they can advise patients appropriately. OBJECTIVE: This article examines the changes that have occurred in contraception over the past decade and discusses the implications of these changes to clinical practice. DISCUSSION: Up-to-date knowledge about how the combined oral contraceptive pill works is reflected in changes to packaging and formulations, with varying success. Other changes include the over-the-counter availability of emergency contraceptive pills and the new combined hormonal vaginal ring. There has been a resurgence in intrauterine device use and their insertion has Level 1 (nonprocedural) indemnity status in most medical defence organisations. Bleeding with long acting progestogen only contraception remains a problem and management options include antiprostaglandins, tranexamic acid, doxycycline, the combined oral contraceptive pill and removal of the device. Sterilisation remains an option for older men and women and newer methods are available. Language: English Keywords: AUSTRALIA | RESEARCH REPORT | KNOWLEDGE | ORAL CONTRACEPTIVES, COMBINED | EMERGENCY CONTRACEPTION | SATISFACTION | VAGINAL RING | STERILIZATION, SEXUAL | INFORMED CHOICE | Oceania | Developed Countries | Sociocultural Factors | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Psychological Factors | Behavior | Contraceptive Usage Document Number: 341574 |
| 4. Title: Combined oral contraceptive pills for treatment of acne. Author: Arowojolu AO; Gallo MF; Lopez LM; Grimes DA; Garner SE Source: Cochrane Database of Systematic Reviews. 2009;(3):CD004425. Abstract: BACKGROUND: Acne is a common skin disorder among women. Although no uniform approach to the management of acne exists, combination oral contraceptives (COCs), which contain an estrogen and a progestin, often are prescribed for women. OBJECTIVES: To determine the effectiveness of combined oral contraceptives (COCs) for the treatment of facial acne compared to placebo or other active therapies. SEARCH STRATEGY: We searched for randomized controlled trials of COCs and acne in the computerized databases of the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, POPLINE, and LILACS. We also searched for clinical trials in ClinicalTrials.gov and the International Clinical Trials Registry Platform (ICTRP). We wrote to authors of identified trials to seek any unpublished or published trials that we might have missed. SELECTION CRITERIA: All randomized controlled trials reported in any language that compared the effectiveness of a COC containing an estrogen and a progestin to placeboor another active therapy for acne in women were eligible. DATA COLLECTION AND ANALYSIS: We extracted data on total and specific (i.e., open or closed comedones, papules, pustules and nodules) facial lesion counts; acne severity grades; global assessments by the clinician or the participant and discontinuation due to adverse events. Data were entered and analyzed in RevMan. MAIN RESULTS: The search yielded 25 trials: 7 placebo-controlled trials made 4 different comparisons, 17 trials made 13 comparisons between 2 different COC regimens, and 1 additional trial compared a COC to an antibiotic. COCs reduced acne lesion counts, severity grades and self-assessed acne compared to placebo. Differences in the comparative effectiveness of COCs containing varying progestin types and dosages, though, were less clear. COCs that contained chlormadinone acetate or cyproterone acetate improved acne better than levonorgestrel, although this apparent advantage was based on limited data. A COC with cyproterone acetate might result in better acne outcomes than one with desogestrel; however, the three studies comparing these COCs produced conflicting results. Likewise, levonorgestrel showed a slight improvement over desogestrel in acne outcomes in one trial, but a second trial found the COC groups were similar. AUTHORS' CONCLUSIONS: The four COCs evaluated in placebo-controlled trials are effective in reducing inflammatory and non-inflammatory facial acne lesions. Few important differences were found between COC types in their effectiveness for treating acne. How COCs compare to alternative acne treatments is unknown since limited data were available regarding this question. Language: English Keywords: GLOBAL | LITERATURE REVIEW | CLINICAL TRIALS | COMPARATIVE STUDIES | WOMEN | ACNE | TREATMENT | ORAL CONTRACEPTIVES, COMBINED | ADMINISTRATION AND DOSAGE | ANTIBIOTICS | HORMONES | Clinical Research | Research Methodology | Studies | Demographic Factors | Population | Dermatitis | Diseases | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Drugs | Endocrine System | Physiology | Biology Document Number: 341912 |
| 5. Peer Reviewed Title: Return to fertility after cessation of a continuous oral contraceptive. Author: Barnhart K; Mirkin S; Grubb G; Constantine G Source: Fertility and Sterility. 2009 May;91(5):1654-6. Abstract: OBJECTIVE: To evaluate the return to fertility among women planning to become pregnant after the use of a continuous regimen of levonorgestrel 90 microg and ethinyl E(2) 20 microg. DESIGN: Descriptive analysis of pregnancy outcomes after participation in a contraceptive trial. SETTING: Multicenter trial. SUBJECT(S): Participants in a phase 3 contraceptive trial who discontinued to become pregnant. INTERVENTION(S): Eligible subjects were contacted at 3 and 12 months after treatment discontinuation to determine if and when they had conceived. MAIN OUTCOME MEASURE(S): Kaplan-Meier analysis displaying the time until conception after oral contraceptive discontinuation. RESULT(S): In the phase 3 trial, 34 of 2,134 subjects cited a desire for pregnancy as a reason for discontinuation. Of these, 4 were already pregnant before stopping treatment, 4 initiated other contraception, and 5 were lost to follow-up. Of the remaining 21 subjects at risk of pregnancy, the pregnancy rate was 57% at 3 months, 81% at 12 months, and 86% (18 of 21) (95% confidence interval 64% to 97%) at 13 months after discontinuation of treatment. CONCLUSION(S): These findings suggest that a continuous oral contraceptive with levonorgestrel 90 microg and ethinyl E(2) 20 microg does not delay the return to fertility. Language: English Keywords: UNITED STATES OF AMERICA | RESEARCH REPORT | CLINICAL TRIALS | WOMEN | ORAL CONTRACEPTIVES, LOW-DOSE | REVERSIBILITY | CONTRACEPTIVE USE-EFFECTIVENESS | Developed Countries | North America | Americas | Clinical Research | Research Methodology | Demographic Factors | Population | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Contraceptive Effectiveness Document Number: 341245 |
| 6. 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 |
| 7. Peer Reviewed Title: Bone mineral density in a cohort of adolescents during use of norethisterone enanthate, depot-medroxyprogesterone acetate or combined oral contraceptives and after discontinuation of norethisterone enanthate. Author: Beksinska ME; Kleinschmidt I; Smit JA; Farley TM Source: Contraception. 2009 May;79(5):345-9. Abstract: BACKGROUND: Depot medroxyprogesterone acetate (DMPA), norethisterone enanthate (NET-EN) and combined oral contraceptives (COCs) have been shown to have a negative effect on bone mineral density (BMD) in adolescents. The aim of this study was to investigate BMD in 15- to 19-year-old new users of DMPA, NET-EN and COCs. STUDY DESIGN: This 5-year longitudinal study followed up new users of DMPA (n=115), NET-EN (n=115) and COCs (n=116) and 144 nonuser controls. BMD was measured at the distal radius using dual-energy X-ray absorptiometry. RESULTS: BMD increased in all groups (annual percent increase: nonusers, 1.49%; DMPA, 1.39%; NET-EN, 1.03%; COCs, 0.84%) during follow-up (p<.001). There was evidence for lower BMD increases per annum in NET-EN (p=.050) and COC (p=.010) users compared to nonusers but no difference between DMPA and nonusers (p=.76). In 14 NET-EN discontinuers, an overall reduction of 0.61% per year BMD was followed upon cessation by an increase of 0.69% per year (p=.066). CONCLUSION: This study suggests that BMD increases in adolescents may be less in NET-EN and COC users; however, recovery of BMD in NET-EN users was found in the small sample of adolescents followed post-discontinuation. Language: English Keywords: SOUTH AFRICA | RESEARCH REPORT | CLINICAL RESEARCH | COHORT ANALYSIS | COMPARATIVE STUDIES | ADOLESCENTS, FEMALE | WOMEN IN DEVELOPMENT | SKELETAL EFFECTS | CONTRACEPTION TERMINATION | NORETHINDRONE ENANTHATE | DEPO-PROVERA | ORAL CONTRACEPTIVES, COMBINED | ORAL CONTRACEPTIVES, SIDE EFFECTS | CONTRACEPTIVE SAFETY | Developing Countries | Africa, Southern | Africa, Sub Saharan | Africa | Research Methodology | Studies | Adolescents | Youth | Age Factors | Population Characteristics | Demographic Factors | Population | Economic Development | Economic Factors | Physiology | Biology | Contraception | Family Planning | Norethindrone | Contraceptive Agents, Progestin | Contraceptive Agents, Female | Contraceptive Agents | Medroxyprogesterone Acetate | Oral Contraceptives | Contraceptive Methods | Safety | Public Health | Health Document Number: 330938 |
| 8. Peer Reviewed Title: Bone mineral density in young women aged 19-24 after 4-5 years of exclusive and mixed use of hormonal contraception. Author: Beksinska ME; Kleinschmidt I; Smit JA; Farley TM; Rees HV Source: Contraception. 2009 Aug;80(2):128-32. Abstract: BACKGROUND: Use of depot-medroxyprogesterone acetate (DMPA), norethisterone enanthate (NET-EN) and low-dose combined oral contraceptives (COCs) has been associated with loss of bone mineral density (BMD) in adolescents. However, the effect of using a combination of these methods over time in this age group is limited. The aim of this cross-sectional study was to investigate BMD in young women (aged 19-24 years) with a history of mixed hormonal contraceptive use. STUDY DESIGN: BMD was measured at the spine, hip and femoral neck using dual X-ray absorptiometry. Women were classified into three groups: (1) injectable users (DMPA, NET-EN or both) (n=40), (2) mixed COC and injectable users (n=13) and (3) non-user control (n=41). RESULTS: Women in the injectables-only user group were found to have lower BMDs compared to the non-user group at all three sites, and there was evidence of a difference in BMD between these two groups at the spine after adjusting for body mass index (p=.042), hip (p=.025) and femoral neck (p=.023). The mixed COC/injectable user group BMD values were lower than those for controls; however, there was no evidence of a significant difference between this group and the non-user group at any of the three sites. CONCLUSION: This study suggests that BMD is lower in long-term injectable users but not when women have mixed injectable and COC use. Language: English Keywords: SOUTH AFRICA | RESEARCH REPORT | CONTROL GROUPS | WOMEN | YOUTH | INJECTABLES | DEPO-PROVERA | ORAL CONTRACEPTIVES, COMBINED | CONTRACEPTIVE AGENTS, SIDE EFFECTS | SKELETAL EFFECTS | Developing Countries | Africa, Southern | Africa, Sub Saharan | Africa | Research Methodology | Demographic Factors | Population | Age Factors | Population Characteristics | Contraceptive Methods | Contraception | Family Planning | Medroxyprogesterone Acetate | Contraceptive Agents, Progestin | Contraceptive Agents, Female | Contraceptive Agents | Oral Contraceptives | Physiology | Biology Document Number: 342307 |
| 9. Title: Combined oral contraceptive use and the risk of systemic lupus erythematosus. Author: Bernier MO; Mikaeloff Y; Hudson M; Suissa S Source: Arthritis and Rheumatism. 2009 Mar 30;61(4):476-481. Abstract: OBJECTIVE: To assess whether the risk of incident systemic lupus erythematosus (SLE) is associated with the use of combined oral contraceptives (COCs), because studies of the link between exogenous hormonal exposure and the risk of SLE have produced conflicting results. METHODS: We conducted a population-based nested case-control study among women ages 18-45 years, using the UK's General Practice Research Database. All incident cases of SLE from 1994-2004 (n = 786) were identified in the database and matched with up to 10 controls (n = 7,817) among women without SLE at the time of the case's diagnosis. RESULTS: The adjusted rate ratio (RR) of incident SLE associated with any use of COC was 1.19 (95% confidence interval [95% CI] 0.98-1.45), whereas with current use it was 1.54 (95% CI 1.15-2.07). The rate was particularly increased in current users who had only recently started COC use (RR 2.52, 95% CI 1.14-5.57) compared with longer-term current users (RR 1.45, 95% CI 1.06-1.99). The risk appearedto be particularly elevated with current exposure to first- or second-generation contraceptives (RR 1.65, 95% CI 1.20-2.26), and increasing with the dose of ethinyl estradiol (RR 1.42, 1.63, and 2.92 for Language: English Keywords: UNITED KINGDOM | RESEARCH REPORT | CLINICAL RESEARCH | EPIDEMIOLOGIC METHODS | CASE CONTROL STUDIES | LONGITUDINAL STUDIES | WOMEN | ORAL CONTRACEPTIVES, COMBINED | SYSTEMIC LUPUS ERYTHEMATOSUS | PREVALENCE | RISK FACTORS | RISK ASSESSMENT | Developed Countries | Europe, Western | Europe | Research Methodology | Studies | Demographic Factors | Population | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Diseases | Measurement | Health | Evaluation Document Number: 330926 |
| 10. Peer Reviewed Title: Developments and challenges in emergency contraception. Author: Black KI Source: Best Practice and Research: Clinical Obstetrics and Gynaecology. 2009 Apr;23(2):221-231. Abstract: Emergency contraception (EC) methods, available in oral and intrauterine forms, seek to prevent pregnancy after unprotected intercourse or contraceptive failure. Levonorgestrel EC is more effective and has fewer side effects than the previously used combined oral hormonal method; the Yuzpe regimen. In recent years, levonorgestrel has increased in use, and has become available over the counter in pharmacies in many countries. compared with oral methods, the copper intra-uterine device offers greater protection against unplanned pregnancy but requires a clinical consultation. The much hoped for potential of EC methods to reduce unintended pregnancy is yet to be demonstrated at population level. Language: English Keywords: GLOBAL | RESEARCH REPORT | CLINICAL RESEARCH | WOMEN | EMERGENCY CONTRACEPTION | LEVONORGESTREL | RU-486 | IUD | ORAL CONTRACEPTIVES, COMBINED | ORAL CONTRACEPTIVES, SIDE EFFECTS | PHARMACY DISTRIBUTION | IUD, COPPER RELEASING | NAUSEA | VOMITING | FATIGUE | PAIN | Research Methodology | Demographic Factors | Population | Contraception | Family Planning | Contraceptive Agents, Progestin | Contraceptive Agents, Female | Contraceptive Agents | Hormone Antagonists | Hormones | Endocrine System | Physiology | Biology | Contraceptive Methods | Oral Contraceptives | Contraceptive Safety | Safety | Public Health | Health | Nonclinical Distribution | Distributional Activities | Program Activities | Programs | Organization and Administration | Signs and Symptoms | Diseases Document Number: 341506 |
| 11. 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 |
| 12. 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 |
| 13. Title: Gonadotropin-releasing hormone analog combined with a low-dose oral contraceptive to treat heavy menstrual bleeding. Author: Cetin NN; Karabacak O; Korucuoglu U; Karabacak N Source: International Journal of Gynaecology and Obstetrics. 2009 Mar;104(3):236-9. Abstract: OBJECTIVE: To compare the effects of low-dose oral contraceptives used alone and in combination with a gonadotropin-releasing hormone (GnRH) analog to treat heavy menstrual bleeding. METHODS: Fifty-eight patients with heavy menstrual bleeding were prospectively randomized into two treatment groups to receive either a low-dose oral contraceptive alone (group 1), or combined with a GnRH analog (group 2) for 6 months. The patients' hormonal profiles, and hemoglobin and hematocrit levels were measured at the beginning and at the end of the treatment period. RESULTS: Hemoglobin and hematocrit levels significantly improved in both groups after 6 months of treatment (P<0.05 and P<0.01, respectively). Even in the first month of the study, the number of pads used and the duration of menstruation were significantly decreased in both groups and markedly lower in group 2 (P<0.01). CONCLUSION: The addition of a GnRH analog to low-dose oral contraceptive treatment for heavy menstrual bleeding resulted in bettercontrol of vaginal bleeding, even in the first month of therapy. Language: English Keywords: TURKEY | RESEARCH REPORT | PROSPECTIVE STUDIES | CLIENTS | MENORRHAGIA | TREATMENT | ORAL CONTRACEPTIVES, LOW-DOSE | GONADOTROPINS | ENDOMETRIAL EFFECTS | Europe, Southeastern | Europe | Developing Countries | Studies | Research Methodology | Program Activities | Programs | Organization and Administration | Menstruation Disorders | Diseases | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Hormones | Endocrine System | Physiology | Biology | Endometrium | Uterus | Genitalia, Female | Genitalia | Urogenital System Document Number: 341388 |
| 14. 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 |
| 15. Title: [The statement of Polish Gynecological Society experts on oral use of contraceptive 75 microg desogestrel minipill in different clinical cases--state of art in 2008] Stanowisko Zespolu Ekspertow Polskiego Towarzystwa Ginekologicznego dotyczace Author: Debski R; Kotarski J; Paszkowski T; Pawelczyk L; Skrzypulec V; Tomaszewski J Source: Ginekologia Polska. 2009 Jan;80(1):63-75. Abstract: Recent epidemiologic studies indicate that use of combined oral contraception is associated with a increase in the incidence of cardiovascular disease (venous thromboembolism, pulmonary embolism, myocardial infarction and stroke). The risk of cardiovascular disease is strongly related to estrogen dose, progestogen type and other factors for example thrombogenic mutations and cigarette smoking among female over age 35. The progestogen only contraception is safe alternative to combined hormonal contraception. Progestogen only pill (POP) has different levels of action (local and/or central) which may vary from one drug to another. As for the cardiovascular disease risk, progestogens are not considered to be risk factors. Desogestrel containing POP is advised in the following cases: bad tolerance of exogenous oestrogens; in order to counteract an endogenous hyperoestrogenosis; medical, metabolic or cardiovascular contraindications to estroprogestogen contraception. Lastly, POP should be used as a prime contraception in some particular situations (breast feeding, endometriosis, adenomyosis, cigarette smoking, contraception for older women). These recommendations present the actual system of care in that population of women in Poland. Language: Polish Keywords: POLAND | RESEARCH REPORT | CLINICAL RESEARCH | EPIDEMIOLOGY | ORAL CONTRACEPTIVES, COMBINED | CONTRACEPTIVE AGENTS, PROGESTIN | PROGESTERONE | CONTRACEPTIVE SAFETY | Developing Countries | Europe, Central | Europe | Research Methodology | Public Health | Health | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Contraceptive Agents, Female | Contraceptive Agents | Progestational Hormones | Hormones | Endocrine System | Physiology | Biology | Safety Document Number: 330922 |
| 16. Title: Thrombophilic conditions in the adolescent: the gynecologic impact. Author: Dietrich JE; Yee DL Source: Obstetrics and Gynecology Clinics of North America. 2009 Mar;36(1):163-75. Abstract: As Virchow's triad suggests, a fine balance exists between the vascular wall, intravascular contents, and dynamic blood flow, such that a shift in this balance predisposes to thrombosis. Although thromboembolic events (TEs) are relatively infrequent in adolescents, the morbidity and mortality associated with TEs can be significant. Over the past 15 years, TEs and inherited and acquired thrombophilic conditions underlying them have become increasingly recognized in teens at risk, with combined hormonal contraception constituting one of the most significant of these risk factors. Therefore, managing gynecologic problems in teens who have thrombophilic conditions can be challenging. It is important to have a clear understanding about safe options available to help address adolescent gynecologic concerns in this setting and to manage situations collaboratively with a hematologist. Language: English Keywords: UNITED STATES OF AMERICA | RECOMMENDATIONS | ADOLESCENTS, FEMALE | GYNECOLOGY | THROMBOSIS | RISK FACTORS | HEREDITARY DISEASES | CONTRACEPTIVE AGENTS, FEMALE | ORAL CONTRACEPTIVES, COMBINED | BLOOD COAGULATION EFFECTS | SCREENING | PROGESTERONE | CONTRACEPTIVE METHODS | Developed Countries | North America | Americas | Adolescents | Youth | Age Factors | Population Characteristics | Demographic Factors | Population | Medicine | Health Services | Delivery of Health Care | Health | Thromboembolism | Embolism | Vascular Diseases | Diseases | Contraceptive Agents | Contraception | Family Planning | Oral Contraceptives | Hematological Effects | Hemic System | Physiology | Biology | Examinations and Diagnoses | Medical Procedures | Progestational Hormones | Hormones | Endocrine System Document Number: 342856 |
| 17. 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 |
| 18. Peer Reviewed Title: Pill scare: communication conundrum. Author: Edouard L Source: Journal of Family Planning and Reproductive Health Care. 2009 Apr;35(2):121-2. Abstract: Adverse publicity for combined oral contraceptives (COCs) has led to pill scares on numerous occasions such as reproductive cancers in 1983 and venous thromboembolism (VTE) in 1995. Misinformation should be avoided, especially through the correct interpretation of relative risk to avoid confusion and decrease unnecessary anxiety. Reassurance is usually important, as the absolute risk is infinitely small. The popular media are very effective for the prompt dissemination of information, and authoritative statements are useful for improving communications with providers, patients and public. Language: English Keywords: ALGERIA | HISTORICAL REVIEW | ORAL CONTRACEPTIVES, COMBINED | ORAL CONTRACEPTIVES, SIDE EFFECTS | MISINFORMATION | FEAR | RISK ASSESSMENT | CANCER | THROMBOEMBOLISM | INFORMATION DISTRIBUTION | PUBLIC HEALTH | Africa, North | Africa | Developing Countries | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Contraceptive Safety | Safety | Health | Communication | Emotions | Psychological Factors | Behavior | Evaluation | Neoplasms | Diseases | Embolism | Vascular Diseases Document Number: 341650 |
| 19. Title: A Canadian, Multicentre Study Comparing the Efficacy of a Levonorgestrel-releasing Intrauterine System to an Oral Contraceptive in Women With Idiopathic Menorrhagia. Author: Endrikat J; Shapiro H; Lukkari-Lax E; Kunz M; Schmidt W; Fortier M Source: Journal of Obstetrics and Gynaecology Canada. 2009 Apr;31(4):340-347. Abstract: Objectives: To evaluate the efficacy of a levonorgestrel-releasing intrauterine system (LNG-IUS) compared with a combined oral contraceptive containing 1 mg norethindrone acetate and 20 mg ethinyl estradiol (OC1/20) in reducing menstrual blood loss (MBL) in women with idiopathic menorrhagia. Methods: A prospective, randomized, open-label study was conducted in nine centres in Canada. Healthy women over 30 years of age suffering from idiopathic menorrhagia were treated either with LNG-IUS (n = 20) or with OC1/20 (n = 19) over 12 months. The primary endpoint was the change in MBL from baseline to 12 months. Secondary endpoints included treatment success (defined as a MBL score < 100 after 12 months), hemoglobin levels, and the menorrhagia severity score. Results: In both treatment groups, MBL decreased significantly from baseline to 12 months (P < 0.001). For the primary endpoint, the MBL score decreased significantly more in the LNG-IUS group (median from 228 to 13, mean percent change-83%) compared to the OC1/20 group (median from 290 to 72; mean percent change-68%) (P = 0.002) after 12 months. In the LNG-IUS group, 80% of subjects had treatment success compared with 36.8 % in the OC1/20 group (P < 0.009). Both treatments increased hemoglobin concentrations significantly between baseline and 12 months. The menorrhagia severity score was consistently lower in the LNG-IUS group at all study time points and was significantly lower (P = 0.045) at six months. Both treatments were well tolerated. Conclusion: Both the LNG-IUS and the combined oral contraceptive effectively decreased menstrual blood loss in women with idiopathic menorrhagia. The overall clinical benefit was more pronounced with LNG-IUS than with OC1/20. Language: English Keywords: CANADA | RESEARCH REPORT | PROSPECTIVE STUDIES | WOMEN | ORAL CONTRACEPTIVES, COMBINED | BLEEDING | MENORRHAGIA | TREATMENT | Developed Countries | North America, Northern | Americas | Studies | Research Methodology | Demographic Factors | Population | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Signs and Symptoms | Diseases | Menstruation Disorders | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health Document Number: 341573 |
| 20. Peer Reviewed Title: Bleeding pattern, tolerance and patient satisfaction with a drospirenone-containing oral contraceptive evaluated in 3488 women in Europe, the Middle East and Canada. Author: Endrikat JS; Milchev NP; Kapamadzija A; Georgievska J; Gerlinger C; Schmidt W; Feroze S Source: Contraception. 2009 Jun;79(6):428-32. Abstract: BACKGROUND: This study was conducted to assess the bleeding pattern, tolerance and patient satisfaction associated with an oral contraceptive (OC) containing 3 mg of drospirenone and 30 mcg of ethinyl estradiol under real-life conditions. STUDY DESIGN: A multicenter, prospective and observational six-cycle study was conducted in 12 countries in Europe, the Middle East and Canada. The efficacy variables included an assessment of bleeding patterns, premenstrual symptoms of water retention and patient satisfaction as determined by a visual analog scale. RESULTS: A total of 3488 women was enrolled in the study. The percentage of women with intermenstrual bleeding decreased from 27.9% at baseline to 5.4% at the end of Cycle 6, while dysmenorrhea decreased from 67% to 17.7%. Also, amenorrhea decreased from 21.3% to 7.5%. The decreases in all three parameters were statistically significant (p<.0001). Approximately 70% of the women reported abdominal bloating and/or breast tenderness at baseline and less than 38% did so at the end of Cycle 6 (p<.0001). Patient satisfaction increased for all investigated items. Upon completion of the study, 86.2% of the women answered "yes" to continuing treatment with this OC. CONCLUSION: The OC containing 3 mg of drospirenone and 30 mcg of ethinyl estradiol has beneficial effects on bleeding pattern, symptoms of water retention and patient satisfaction. Language: English Keywords: EUROPE | MIDDLE EAST | CANADA | RESEARCH REPORT | CLINICAL RESEARCH | PROSPECTIVE STUDIES | KAP SURVEYS | WOMEN | BLEEDING | SATISFACTION | ORAL CONTRACEPTIVES, COMBINED | ESTRADIOL | CONTRACEPTIVE SAFETY | AMENORRHEA | METRORRHAGIA | Developed Countries | North America, Northern | Americas | Research Methodology | Studies | Surveys | Sampling Studies | Demographic Factors | Population | Signs and Symptoms | Diseases | Psychological Factors | Behavior | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Estrogens | Hormones | Endocrine System | Physiology | Biology | Safety | Public Health | Health | Menstruation Disorders Document Number: 341103 |
| 21. Title: Endometrial hyperplasia risk in relation to recent use of oral contraceptives and hormone therapy. Author: Epplein M; Reed SD; Voigt LF; Newton KM; Holt VL; Weiss NS Source: Annals of Epidemiology. 2009 Jan;19(1):1-7. Abstract: PURPOSE: We sought to examine the relationship between recent use of oral contraceptives and hormone therapy and endometrial hyperplasia (EH) risk. METHODS: Cases comprised women diagnosed with complex EH (n = 289) or atypical EH (n = 173) between 1985 and 2003. One age-matched control was selected for each case; excluded were women with a prior hysterectomy or diagnosis of EH or endometrial cancer. Hormone use in the 6 months prior to the date of the case's first symptoms was ascertained using a pharmacy database and medical records. Odds ratios (OR) and 95% confidence intervals (CI) were calculated. RESULTS: Three (1.1%) cases had used oral contraceptives, compared to 16 (6.0%) controls (OR = 0.2, 95% CI: 0.0-0.6). Fifty-one (16.8%) cases had taken estrogen-only hormone therapy, in contrast to two (0.7%) controls (OR = 37.6, 95% CI: 8.8-160.0). The risk of EH among estrogen plus progestin hormone users did not differ from that of non-users (OR = 0.7, 95% CI: 0.4-1.1). CONCLUSIONS: This study suggests that previous findings of the association of estrogen-only hormone therapy with increased risk of EH and the lack of an association between estrogen plus progestin hormone therapy and EH risk are likely to apply to both complex EH and atypical EH. Further examination of the association between oral contraceptives and EH, with greater numbers of OC users, is warranted. Language: English Keywords: WASHINGTON | RESEARCH REPORT | EPIDEMIOLOGIC METHODS | CLINICAL RESEARCH | CASE CONTROL STUDIES | WOMEN | PREVALENCE | ENDOMETRIAL CANCER | HORMONE REPLACEMENT THERAPY | CONTRACEPTIVE SAFETY | ORAL CONTRACEPTIVES, SIDE EFFECTS | TIME FACTORS | CONTRACEPTIVE AGENTS, ESTROGEN | ORAL CONTRACEPTIVES, COMBINED | CONTRACEPTIVE AGENTS, PROGESTIN | United States of America | North America | Americas | Developed Countries | Research Methodology | Studies | Demographic Factors | Population | Measurement | Cancer | Neoplasms | Diseases | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Safety | Public Health | Population Dynamics | Contraceptive Agents, Female | Contraceptive Agents | Contraception | Family Planning | Oral Contraceptives | Contraceptive Methods Document Number: 330386 |
| 22. Peer Reviewed Title: Combined oral contraceptive and intrauterine device use among women with gestational trophoblastic disease. Author: Gaffield ME; Kapp N; Curtis KM Source: Contraception. 2009 Oct;80(4):363-71. Abstract: BACKGROUND: Women diagnosed with gestational trophoblastic disease (GTD) need safe and effective contraception because they are advised to delay a subsequent pregnancy. STUDY DESIGN: We searched MEDLINE and The Cochrane Library for articles in any language on use of combined oral contraceptives (COC), copper-bearing or levonorgestrel-releasing IUDs among women with benign or malignant GTD, from database inception through November 2008. One review and nine articles were identified and evaluated. RESULTS: Incidence of postmolar trophoblastic disease was lower among COC users compared with nonusers in six studies, but higher among COC users in three studies. Five studies reported shorter human chorionic gonadotropin (hCG) regression duration among COC users compared with other methods. Development of postmolar trophoblastic disease did not differ significantly among IUD users compared with COC users or nonusers in three studies. CONCLUSIONS: Evidence shows that postmolar trophoblastic disease risk does not increase among women using COCs or an IUD following molar pregnancy evacuation compared with use of other contraceptive methods or no method. Language: English Keywords: GLOBAL | LITERATURE REVIEW | CLINICAL RESEARCH | NEOPLASMS | FETAL MEMBRANES | PREGNANCY COMPLICATIONS | CANCER | GONADOTROPINS, CHORIONIC | ORAL CONTRACEPTIVES, COMBINED | IUD, COPPER RELEASING | IUD, HORMONE RELEASING | CONTRACEPTIVE SAFETY | Research Methodology | Diseases | Fetus | Pregnancy | Reproduction | Gonadotropins | Hormones | Endocrine System | Physiology | Biology | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | IUD | Safety | Public Health | Health Document Number: 342770 |
| 23. Peer Reviewed Title: Use of combined oral contraceptives post abortion. Author: Gaffield ME; Kapp N; Ravi A Source: Contraception. 2009 Oct;80(4):355-62. Abstract: BACKGROUND: Providing combined oral contraceptives (COCs) following surgical or medical induced abortion offers women an opportune moment to initiate a reliable contraceptive method. STUDY DESIGN: We conducted a systematic review, searching MEDLINE and The Cochrane Library for articles in any language concerning COC use following spontaneous, induced (medical or surgical) or septic abortion, from 1966 through June 2008. Seven articles were identified and evaluated using the United States Preventive Services Task Force system. RESULTS: Immediate COC initiation after first-trimester medical or surgical induced abortion did not increase side effects or prolong vaginal bleeding compared with use of a placebo, copper-bearing intrauterine device (IUD), nonhormonal contraceptive method or COC initiation at a later time. Initiating COCs after first-trimester surgical abortion produced small increases in coagulation parameters compared with IUD use; although they are statistically significant, their clinical relevance is unlikely. No study examined second-trimester induced or spontaneous abortion, or septic abortion. CONCLUSIONS: Evidence shows that COCs can be safely initiated immediately following surgical and medical abortion in the first-trimester of pregnancy. Language: English Keywords: GLOBAL | LITERATURE REVIEW | ABORTION | ABORTION, SPONTANEOUS | PREGNANCY, FIRST TRIMESTER | POSTABORTION CARE | ORAL CONTRACEPTIVES, COMBINED | CONTRACEPTIVE SAFETY | MENSTRUATION | ORAL CONTRACEPTIVES, SIDE EFFECTS | BLOOD COAGULATION EFFECTS | Fertility Control, Postconception | Family Planning | Pregnancy Complications | Diseases | Pregnancy | Reproduction | Health Services | Delivery of Health Care | Health | Oral Contraceptives | Contraceptive Methods | Contraception | Safety | Public Health | Hematological Effects | Hemic System | Physiology | Biology Document Number: 342771 Notification |
24.  Title: [Descriptive study on contraceptive requirements for clinical trials in Spain. Do we need a debate?] Estudio descriptivo de las recomendaciones anticonceptivas en los ensayos Author: Gastaminza Lasarte G; Algorta Pineda J Source: Medicina Clinica. 2009 Jan 24;132(2):70-4. Abstract: Among the measures that seek to avoid the toxic effects on reproduction (teratogenic, embryotoxic, fetotoxic or otherwise) include the obligation to conduct preclinical tests to investigate this aspect in different animal species before marketing a new drug, although its application in time differs Europe-European Medicines Agency (EMEA) and US-Food and Drug Administration (FDA). In Europe requires that prior to including women in phase I of clinical trials have been completed preclinical studies on embryo-fetal development, without any mention of contraception. In contrast, U.S. can include women in the fertile clinical trials have not completed initial pre-clinical tests on the safety play, if they practice a pregnancy test before participation in contraception and take some action "highly effective". Are considered "highly effective" (by both the FDA and the EMEA, to be included in a document of the International Conference on Harmonization) methods with low failure rate (<1% per year) when used properly, such as implants, injectables, combined oral, some intrauterine devices (IUDs), sexual abstinence or a vasectomy for the partner. (excerpt) Language: Spanish Keywords: SPAIN | RESEARCH REPORT | CLINICAL TRIALS | PREGNANCY TESTS | ORAL CONTRACEPTIVES, COMBINED | IUD | INJECTABLES | CONTRACEPTIVE IMPLANTS | VASECTOMY | Europe, Southwestern | Europe | Developed Countries | Clinical Research | Research Methodology | Laboratory Procedures | Laboratory Examinations and Diagnoses | Examinations and Diagnoses | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Male Sterilization | Sterilization, Sexual Document Number: 329576 |
| 25. Title: Oral contraceptives for functional ovarian cysts. Author: Grimes DA; Jones LB; Lopez LM; Schulz KF Source: Cochrane Database of Systematic Reviews. 2009;(2):CD006134. Abstract: BACKGROUND: Functional ovarian cysts are a common gynecological problem among women of reproductive age worldwide. When large, persistent, or painful, these cysts may require operations, sometimes resulting in removal of the ovary. Since early oral contraceptives were associated with a reduced incidence of functional ovarian cysts, many clinicians inferred that birth control pills could be used to treat cysts as well. This became a common clinical practice in the early 1970s. OBJECTIVES: This review examined all randomized controlled trials that studied oral contraceptives as therapy for functional ovarian cysts. SEARCH STRATEGY: We searched the databases of CENTRAL, MEDLINE, POPLINE, and EMBASE, as well as clinical trials databases (ClinicalTrials.gov and ICTRP). We also examined the reference lists of articles and wrote to authors of identified trials to seek articles we had missed. SELECTION CRITERIA: We included randomized controlled trials in any language that included oral contraceptives used for treatment and not prevention of functional ovarian cysts. Criteria for diagnosis of cysts were those used by authors of trials. DATA COLLECTION AND ANALYSIS: Two authors independently abstracted data from the articles. One entered the data into RevMan and a second verified accuracy of data entry. For dichotomous outcomes, we used Peto odds ratios with 95% confidence intervals (CI). For continuous outcomes, we calculated mean differences with 95% CI. MAIN RESULTS: We identified seven randomized controlled trials from four countries; the studies included a total of 500 women. Treatment with combined oral contraceptives did not hasten resolution of functional ovarian cysts in any trial. This held true for cysts that occurred spontaneously as well as those that developed after ovulation induction. Most cysts resolved without treatment within a few cycles; persistent cysts tended to be pathological (e.g., endometrioma or para-ovarian cyst) and not physiological. AUTHORS' CONCLUSIONS: Although widely used fortreating functional ovarian cysts, combined oral contraceptives appear to be of no benefit. Watchful waiting for two or three cycles is appropriate. Should cysts persist, surgical management is often indicated. Language: English Keywords: LITERATURE REVIEW | CLINICAL TRIALS | WOMEN | OVARIAN CYSTS | ORAL CONTRACEPTIVES, COMBINED | ORAL CONTRACEPTIVES, SIDE EFFECTS | TREATMENT | Clinical Research | Research Methodology | Demographic Factors | Population | Diseases | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Contraceptive Safety | Safety | Public Health | Health | Medical Procedures | Medicine | Health Services | Delivery of Health Care Document Number: 330972 |
| 26. Title: ST elevation myocardial infarction in young adult females [editorial] Author: Gujral JS Source: Southern Medical Journal. 2009 May;102(5):460. Abstract: The author questions whether myocardial infarction (MI) in youg adult females less than 35 years of age id due to the increased prevalence of atherosclerotic heart disease in the younger population and suggests that the most likely culprit causing thrombosis in the right coronary artery in this patient could be a combination of smoking and hormonal contraception. Language: English Keywords: UNITED STATES OF AMERICA | SUMMARY REPORT | WOMEN | CARDIOVASCULAR EFFECTS | MYOCARDIAL INFARCTION | TOBACCO USE | ORAL CONTRACEPTIVES, COMBINED | RISK FACTORS | EMERGENCY SERVICES | Developed Countries | North America | Americas | Demographic Factors | Population | Physiology | Biology | Heart Diseases | Diseases | Behavior | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Health | Health Services | Delivery of Health Care Document Number: 341206 |
| 27. 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 |
| 28. Peer Reviewed Title: Depot-medroxyprogesterone acetate and combined oral contraceptive use and cervical neoplasia among women with oncogenic human papillomavirus infection. Author: Harris TG; Miller L; Kulasingam SL; Feng Q; Kiviat NB; Schwartz SM; Koutsky LA Source: American Journal of Obstetrics and Gynecology. 2009 May;200(5):489.e1-8. Abstract: OBJECTIVE: The objective of the study was to examine the relationship of depot-medroxyprogesterone acetate (DMPA) and combined oral contraceptive (COC) use with cervical intraepithelial neoplasia (CIN). STUDY DESIGN: Two case-control studies of women who presented for gynecologic care and underwent cytologic and human papillomavirus (HPV) testing were performed. The first included oncogenic HPV-positive women grouped based on histology: negative (n = 152), CIN1 (n = 133), and CIN2-3 or greater (n = 173). For the second, 2 groups were identified: negative HPV/negative histology (n = 107) and positive oncogenic HPV/negative histology (n = 152). RESULTS: Among oncogenic HPV-positive women, DMPA use was inversely associated with CIN2-3 or greater (adjusted odds ratio [OR(adj)], 0.4; 95% confidence interval [CI], 0.2-1.1) and CIN1 (OR(adj), 0.1; 95% CI, 0.01-0.6); COC use was not associated with either. Among histologically negative women, DMPA use was associated with oncogenic HPV (OR(adj), 4.7; 95% CI, 1.4-15.8). CONCLUSION: Among women with oncogenic HPV, hormonal contraceptive use was not associated with an increased risk of CIN2-3 or greater. Longer-term DMPA use may attenuate the colposcopic and histologic features of CIN because women reporting such use were more likely than others to have cervical oncogenic HPV without evidence of CIN. Language: English Keywords: UNITED STATES OF AMERICA | RESEARCH REPORT | EPIDEMIOLOGIC METHODS | CLINICAL RESEARCH | CASE CONTROL STUDIES | WOMEN | PREVALENCE | HPV | CERVICAL CANCER | RISK FACTORS | DEPO-PROVERA | ORAL CONTRACEPTIVES, COMBINED | RISK ASSESSMENT | COLPOSCOPY | HISTOLOGY | Developed Countries | North America | Americas | Research Methodology | Studies | Demographic Factors | Population | Measurement | Viral Diseases | Diseases | Cancer | Neoplasms | Health | Medroxyprogesterone Acetate | Contraceptive Agents, Progestin | Contraceptive Agents, Female | Contraceptive Agents | Contraception | Family Planning | Oral Contraceptives | Contraceptive Methods | Evaluation | Endoscopy | Physical Examinations and Diagnoses | Examinations and Diagnoses | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Biology Document Number: 331078 |
| 29. 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 |
| 30. Title: Valproate and lamotrigine level variation with menstrual cycle phase and oral contraceptive use. Author: Herzog AG; Blum AS; Farina EL; Maestri XE; Newman J; Garcia E; Krishnamurthy KB; Hoch DB; Replansky S; Fowler KM; Smithson SD; Dworetzky BA; Bromfield EB Source: Neurology. 2009 Mar 10;72(10):911-4. Abstract: OBJECTIVE: To determine whether 1) combined oral contraceptive (COC) use affects serum levels of valproate (VPA) as well as lamotrigine (LTG) and 2) the naturally occurring high (mid-luteal) and low (early-mid follicular) reproductive steroid level phases of the menstrual cycle might affect antiepileptic drug levels as well. METHODS: This investigation compared serum antiepileptic drug levels at two timepoints during a single menstrual cycle in four groups of women with epilepsy: 12 on VPA, 12 on VPA plus COC (VPA-COC), 12 on LTG, and 12 on LTG plus COC (LTG-COC). RESULTS: Both VPA and LTG levels were lower (p < 0.01) on active COC than on inactive pill with median declines of 23.4% for the VPA-COC group and 32.6% for the LTG-COC group. Serum LTG levels showed a notable but not significant 31.3% median decline during the mid-luteal phase compared to the early-mid follicular phase in the non-COC group. The non-COC valproate group showed the least change of any group between the two measured timepoints with a decline of 8.3% (p = NS). CONCLUSIONS: The findings suggest that valproate (VPA), like lamotrigine (LTG), has substantially and significantly lower serum levels while women take active combined oral contraceptives as compared to inactive pills. Larger sample sizes will be required to determine whether LTG levels may drop significantly also during the luteal (high steroid) phase of natural menstrual cycles and whether VPA levels may show greater stability in levels across the phases of the menstrual cycle. Language: English Keywords: UNITED STATES OF AMERICA | RESEARCH REPORT | WOMEN | NEUROLOGIC EFFECTS | ORAL CONTRACEPTIVES, COMBINED | DRUGS | DRUG INTERACTIONS | MENSTRUATION | Developed Countries | North America | Americas | Demographic Factors | Population | Physiology | Biology | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Reproduction Document Number: 330553 |
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