1.  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 |
| 2. 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 |
| 3. 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 |
| 4. 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 |
| 5. Peer Reviewed Title: Adding low-dose estrogen to the hormone-free interval: impact on bleeding patterns in users of a 91-day extended regimen oral contraceptive. Author: Kaunitz AM; Portman DJ; Hait H; Reape KZ Source: Contraception. 2009 May;79(5):350-5. Abstract: BACKGROUND: A cross-study analysis of contraceptive clinical trials for two different 91-day oral contraceptive (OC) regimens was performed to examine the impact on bleeding patterns when supplementing the 7-day hormone-free interval with 10 mcg ethinyl estradiol (EE) daily. STUDY DESIGN: Two separate 1-year Phase 3 clinical programs were conducted using similar study designs. The percentages of subjects reporting bleeding and spotting using electronic diaries for each 91-day cycle were compared. RESULTS: Scheduled bleeding with the EE regimen was less than that reported with the regimen utilizing placebo during Days 85-91, with significant differences noted for all four 91-day cycles. Unscheduled bleeding decreased more quickly with the 91-day regimen containing low-dose EE in place of placebo, with significant differences noted during the third cycle. CONCLUSIONS: This cross-study comparison suggests that the administration of low-dose estrogen in place of placebo in a 91-day extended regimen OCimproves the bleeding profile. Language: English Keywords: NORTH AMERICA, NORTHERN | LITERATURE REVIEW | CLINICAL TRIALS | WOMEN | BLEEDING | ORAL CONTRACEPTIVES, SIDE EFFECTS | ORAL CONTRACEPTIVES, LOW-DOSE | CONTRACEPTIVE AGENTS, ESTROGEN | TIME FACTORS | ADMINISTRATION AND DOSAGE | ETHINYL ESTRADIOL | Americas | Developed Countries | Clinical Research | Research Methodology | Demographic Factors | Population | Signs and Symptoms | Diseases | Contraceptive Safety | Safety | Public Health | Health | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Contraceptive Agents, Female | Contraceptive Agents | Population Dynamics | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care Document Number: 330939 |
| 6. Title: The effects of hormonal contraception. Author: Kent A Source: Reviews In Obstetrics and Gynecology. 2009 Winter;2(1):66. Abstract: There are many claims made about the beneficial effects of hormonal contraceptives other than their ability to prevent pregnancy. Studies have tracked women's responses to oral contraceptives (OCs) or depot medroxyprogesterone acetate (DMPA), but few have taken into account the woman's entry status or baseline symptoms, and fewer still have looked at control groups on nonhormonal contraception. Another problem has been the duration of follow-up, which should be longer than 1 year to properly assess the steady state of a changed hormonal environment. A study by Berenson and colleagues deals with the issues of baseline status and prolonged use in a series of women using injectable DMPA and low-dose OCs (typically 20 microg estrogen-containing pills). The first important finding was that symptoms are common in the absence of contraceptive use, such as acne, cyclical mastalgia, cramping, and mood swings. They found these symptoms improved on sustained use of OCs compared with control groups, and therewas no evidence that depression was a problem, despite lowered mood being a commonly quoted negative effect among those prescribing OCs. The most frequent side effect was intermenstrual bleeding with OCs and an increased risk of bleeding for more than 20 days, amenorrhea, weight gain, and loss of energy and libido on DMPA. Most of these effects resolved after 6 months and almost all resolved by 12 months, with amenorrheaic women often welcoming the side effect. Finally, the researchers found that women were not clearly informed of the potential side effects, or of their resolution with ongoing use. They recommend careful counseling about what to expect and more frequent follow-up after initiation to provide reassurance or a change to another method if required. (full-text) Language: English Keywords: SOUTH AFRICA | RESEARCH REPORT | CLINICAL RESEARCH | COMPARATIVE STUDIES | WOMEN IN DEVELOPMENT | INJECTABLES | PSYCHOLOGICAL FACTORS | PHYSIOLOGY | CONTRACEPTIVE AGENTS, SIDE EFFECTS | DEPO-PROVERA | ORAL CONTRACEPTIVES, LOW-DOSE | CONTRACEPTIVE AGENTS, ESTROGEN | METRORRHAGIA | ADMINISTRATION AND DOSAGE | BREAST CANCER | Developing Countries | Africa, Southern | Africa, Sub Saharan | Africa | Research Methodology | Studies | Economic Development | Economic Factors | Contraceptive Methods | Contraception | Family Planning | Behavior | Biology | Contraceptive Agents | Medroxyprogesterone Acetate | Contraceptive Agents, Progestin | Contraceptive Agents, Female | Oral Contraceptives | Bleeding | Signs and Symptoms | Diseases | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Cancer | Neoplasms Document Number: 331284 |
| 7. Title: Hormonal contraception and bone mineral density. Author: Kent A Source: Reviews In Obstetrics and Gynecology. 2009 Winter;2(1):66-7. Abstract: Hormonal contraceptives negatively affect bone mass density (BMD), but the effect is small and reversible. Low-dose OCs in young women are associated with less than 0.5% BMD loss in the hip and spine. Berenson and colleagues also looked at BMD changes with DMPA and found up to a 5% loss. This is potentially significant in young women. They discovered that the effect was temporary and those who stopped using DMPA gained BMD at about 2.5% per year. Overall, the benefits of hormonal contraception far outweigh the risks. (full-text) Language: English Keywords: SOUTH AFRICA | RESEARCH REPORT | CLINICAL RESEARCH | WOMEN IN DEVELOPMENT | DEPO-PROVERA | SKELETAL EFFECTS | OSTEOPOROSIS | ORAL CONTRACEPTIVES, LOW-DOSE | Developing Countries | Africa, Southern | Africa, Sub Saharan | Africa | Research Methodology | Economic Development | Economic Factors | Medroxyprogesterone Acetate | Contraceptive Agents, Progestin | Contraceptive Agents, Female | Contraceptive Agents | Contraception | Family Planning | Physiology | Biology | Oral Contraceptives | Contraceptive Methods Document Number: 331285 |
| 8. 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 |
| 9. Title: The Transnational study of oral contraceptive cardiovascular safety: history and science. Author: Suissa S Source: Journal of Clinical Epidemiology. 2009;62:588-593. Abstract: This study, in which Kuhl et al. reported elevated ethinyl estradiol (EE) levels in women receiving the gestodene/EE combination oral contraceptives (OCs) compared with desogestrel-containing combination OCs, by its implication that such differences could be associated with increased cardiovascular risks, had attracted much publicity and created great concern in Germany. The working group found sufficient methodological deficiencies in the Kuhl study to question the validity of its findings of significant differences in effects between the various OCs. Besides a large number of studies mostly irrelevant to the issue of cardiovascular risk, Schering had conducted a large postmarketing phase IV study in over 100,000 women. Joe Fleiss, who was the primary reviewer of that report, presented the shortest review I had ever witnessed: he raised the thick report in the air and simply tossed it on the floor. It was clear to all that the data were simply unreliable and unusable to address this safety concern. The working group thus recommended that the only way to address the safety issue regarding gestodene was to conduct epidemiological studies on the safety of all newer low-dose OCs and saw it as an international priority, particularly in view of the number of newer OCs that had been brought to market and the scarcity of recent published studies. Schering agreed in principle to fund such research, and Walter coordinated the writing of protocols for a research program that included three studies. The Trinational study, a field case-control study conducted in three European countries was the only one retained. The Value Added Medical Products (VAMP), the predecessor of the General Practice Research Database (GPRD), historical cohort study was rejected for political (no data on German women) and scientific reasons, such as the absence of important confounder data and insufficient OC history. The Saskatchewan study was rejected because gestodene was not available in Saskatchewan, and other low-dose COCs, by themselves, were not relevant to the sponsors. (excerpt) Language: English Keywords: EUROPE, WESTERN | CONFERENCES AND CONGRESSES | CLINICAL RESEARCH | EPIDEMIOLOGIC METHODS | CROSS-CULTURAL COMPARISONS | WOMEN | CONTRACEPTIVE SAFETY | ORAL CONTRACEPTIVES | CARDIOVASCULAR EFFECTS | GESTODENE | ORAL CONTRACEPTIVES, COMBINED | DESOGESTREL | ORAL CONTRACEPTIVES, LOW-DOSE | LOW-DOSE PROGESTINS | NORTH AMERICA, NORTHERN | Europe | Developed Countries | Research Methodology | Comparative Studies | Studies | Demographic Factors | Population | Safety | Public Health | Health | Contraceptive Methods | Contraception | Family Planning | Physiology | Biology | Contraceptive Agents, Progestin | Contraceptive Agents, Female | Contraceptive Agents | Americas Document Number: 331005 |
| 10. Title: [The influence of a combined low dose oral contraceptive containing drospirenone on electrolite equlibrum and renal function in young woman] Wplyw stosowania zlozonej, nisko- estrogenowej tabletki antykoncepcyjnej Author: Szlendak-Sauer K; Radowicki S; Skorzewska K Source: Ginekologia Polska. 2009 Jan;80(1):33-7. Abstract: Drospirenone--a new 17 alpha-spironolactone derivate is a progestin with aldosterone receptor antagonism activity (PARA) thanks to which it decreases sodium and fluid retention. THE AIM: The aim of our study was to estimate the electrolytes level and renal function parameters in blood during the therapy of low dose oral contraceptive containing drospirenone. MATERIAL AND METHODS: The group consisted of 22 young women in mean age 25,9 +/- 4,3 years, without contraindications to hormonal contraception used specimen containing 20 microg ethinyloestradiol and 3.0 mg drospirenone during 12 cycles. Blood levels of electrolytes (sodium, potassium, calcium, phosphorus and chloride) and renal function parameters (creatinine, urea and uric acid) were evaluated before and after 3, 6 and 12 cycles of the treatment RESULTS: There were no statistically significant differences observed in serum concentration of electrolytes and renal function parameters. CONCLUSION: The therapy of a low dose oral contraceptive containing 20 microg ethinyloestradiol and 3.0 mg drospirenone does not influence the electrolyte equilibrium and renal function. Language: Polish Keywords: RESEARCH REPORT | EVALUATION | WOMEN | ORAL CONTRACEPTIVES | ORAL CONTRACEPTIVES, LOW-DOSE | CONTRACEPTIVE SAFETY | Demographic Factors | Population | Contraceptive Methods | Contraception | Family Planning | Safety | Public Health | Health Document Number: 330921 |
| 11. Title: [Oral contraception - dosis and way of administration] Hormonale Kontrazeption - Dosierung und Verabreichungsformen. Author: Thaler C; Kuhl H; Mueck A; Birkhauser M; Braendle W; Neulen J; Keller PJ; Kiesel L Source: therapeutische Umschau. Revue therapeutique. 2009 Feb;66(2):93-9. Abstract: Since the correlation between the amount of Ethinylestradiol (EE) and the thromboembolic risk has been recognized, the development of new oral contraceptives (OC) has been characterized by a constant lowering of the EE dosage. The consecutive decrease of ovulation inhibition has been compensated by the introduction of potent progestagens. Therefore, the contraceptive safety has been maintained in presence of less side-effects. The effect of ultra-low-dose OC on acne and seborrhea remains beneficial. The effect of ultra-low-dose OC on bone is contradictory. Because there are fundamental differences between Estradiol and EE, the thromboembolic risk is not decreased by the parenteral administration of EE. In users of the contraceptive patch, it is even increased. EE is not bound at SHBG. Because of its Ethinyl group, the inactivation of EE occurs slowly. Therefore, EE reaches the liver in a low but constant concentration where it modifies many estrogen-dependent hepatic parameters significantly. One of these is hemostasis. It is generally accepted that such changes are responsable for the increased thromboembolic risk of the contraceptive patch and vaginalring. A reduction of the homone-free interval of the pill to 5 or 4 days results in a complete suppression of the ovarian function, a reliable ovulation inhibition and an increase of the contraceptive efficacy in spite of a reduction of the EE dosage to 20 mug or 15 mug. Language: German Keywords: RESEARCH REPORT | CONTRACEPTIVE SAFETY | ORAL CONTRACEPTIVES, LOW-DOSE | ACNE | ADMINISTRATION AND DOSAGE | Safety | Public Health | Health | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Dermatitis | Diseases | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care Document Number: 329573 |
| 12. Title: St John's wort extract (Ze 117) does not alter the pharmacokinetics of a low-dose oral contraceptive. Author: Will-Shahab L; Bauer S; Kunter U; Roots I; Brattstrom A Source: European Journal of Clinical Pharmacology. 2009 Mar;65(3):287-94. Abstract: PURPOSE: St John's wort (Hypericum perforatum) is an herbal remedy that is widely used in the treatment of depression. Recent clinical data have demonstrated that St John's wort extracts interfere with the action of various drugs and possibly also with combined oral contraceptives. Therefore, we investigated the effects of a St John's wort extract (Ze 117) with low hyperforin content on the pharmacokinetics of ethinylestradiol and 3-ketodesogestrel. METHOD: Sixteen healthy female volunteers, who had taken a low-dose oral contraceptive (Lovelle contains 0.02 mg ethinylestradiol + 0.15 mg desogestrel) for at least 3 months, participated in the study. Pharmacokinetic data (AUC, C(max), t(max)) were determined the day before (reference) and after (test) a 14-day period of Ze 117 intake (250 mg twice daily). RESULTS: Before the co-administration of Ze 117 on day 7, the geometric mean (geometric coefficient of variation) for the AUC(0-24) of ethinylestradiol was 152.53 pg.h/ml (87.39%) and after co-administration on day 21 it was 196.57 pg.h/ml (78.14%). The respective values for ketodesogestrel were 36.37 pg.h/ml (34.18%) and 41.12 pg.h/ml (34.36%). The mean of individual ratios (reference-to-test) of log-transformed AUC values (90% confidence interval) were 0.951 (0.915-0.986) for ethinylestradiol and 0.968 (0.944-0.992) for ketodesogestrel indicating a small loss in bioavilability, but bioequivalence nevertheless. CONCLUSION: These results indicate that the recommended dose of the hypericum extract Ze117, which has a low hyperforin content, does not interact with the pharmacokinetics of the hormonal components of the low-dose oral contraceptive. Language: English Keywords: FEDERAL REPUBLIC OF GERMANY | RESEARCH REPORT | CLINICAL RESEARCH | WOMEN | ORAL CONTRACEPTIVES, COMBINED | ORAL CONTRACEPTIVES, LOW-DOSE | ETHINYL ESTRADIOL | DESOGESTREL | DRUG INTERACTIONS | Developed Countries | Europe, Central | Europe | Research Methodology | Demographic Factors | Population | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Contraceptive Agents, Estrogen | Contraceptive Agents, Female | Contraceptive Agents | Contraceptive Agents, Progestin | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health Document Number: 330997 |
| 13. Peer Reviewed Title: Mifepristone as an anti-implantation contraceptive drug: roles in regulation of uterine natural killer cells during implantation phase. Author: Zhu HX; Zhang WW; Zhuang YL; Huang LL Source: American Journal of Reproductive Immunology. 2009 Jan;61(1):68-74. Abstract: PROBLEM: To investigate the immunological mechanism of low-dose mifepristone acting as a contraceptive at the level of the endometrium. METHOD OF STUDY: Endometrial explants were cultured in vitro with or without mifepristone treatment for 24 hr. Some tissues were fixed and immunostained for CD56, while other tissues were dissociated and cells analysed by three colour flow cytometry for CD3, CD56 and CD16. RESULTS AND CONCLUSION: Results showed a significant increase in the number of CD56(+) natural killer (NK) cells and the percentages of CD3(-) CD56(+) CD16(-) NK cell subset in the tissue treated with mifepristone, while the percentage of CD3(-) CD56(+) CD16(+) NK cell subset remained unaffected. It shows that low-dose mifepristone increases the number of CD56(+) NK cells and the percentage of CD3(-) CD56(+) CD16(-) NK subset in receptive endometrium and provides new insights into the immunological mechanism of low-dose mifepristone as an anti-implantation contraceptive drug. Language: English Keywords: CHINA | RESEARCH REPORT | CLINICAL RESEARCH | WOMEN IN DEVELOPMENT | IMPLANTATION | IMMUNITY, CELLULAR | UTERUS | RU-486 | ORAL CONTRACEPTIVES, LOW-DOSE | ORAL CONTRACEPTIVES, SIDE EFFECTS | IMPLANTATION SUPPRESSION | Asia, Eastern | Asia | Developing Countries | Research Methodology | Economic Development | Economic Factors | Pregnancy, First Trimester | Pregnancy | Reproduction | Immunity | Immune System | Physiology | Biology | Genitalia, Female | Genitalia | Urogenital System | Hormone Antagonists | Hormones | Endocrine System | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Contraceptive Safety | Safety | Public Health | Health | Contraceptive Mode of Action Document Number: 330062 |
14.  Title: Effect of low dose oral pill on haemostatic parameters in a set of Pakistani population. Author: Afsar NA; Barakzai Q; Adil SN Source: Journal of Pakistan Medical Association. 2008 May;58(5):229-233. Abstract: The purpose of this study was to observe the adverse effects of low dose combination contraceptive pills on blood coagulation in a set of local population. Between December 2002 to December 2003 a comparative cross-sectional study was conducted at the Department of Pharmacology, Ziauddin Medical University, Karachi and Aga Khan University Hospital, Karachi. Fifty women of reproductive age were divided in two equal groups; one being the users of combination oral contraceptive pills (ethinyl estradiol and levonorgestrel) and the other being matching controls not taking any hormonal contraceptives. We studied, CBC, PT and INR, APTT, BT and platelet aggregation against ADP, collagen, epinephrine and ristocetin. PT, INR, and platelet aggregation response to ADP, collagen, epinephrine, and ristocetin were not significantly different among the groups. However, APTT was shortened in users of contraceptives (p = 0.003). The referred oral contraceptive is associated with enhanced activity of intrinsic pathway of secondary haemostasis. (author's) Language: English Keywords: PAKISTAN | RESEARCH REPORT | COMPARATIVE STUDIES | CROSS SECTIONAL ANALYSIS | WOMEN | ORAL CONTRACEPTIVES, COMBINED | ORAL CONTRACEPTIVES, LOW-DOSE | BLOOD COAGULATION EFFECTS | Developing Countries | Asia, Southern | Asia | Studies | Research Methodology | Demographic Factors | Population | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Hematological Effects | Hemic System | Physiology | Biology Document Number: 327014 |
| 15. Title: Effect of antiepileptic drugs on oral contraceptives. Author: Carl JS; Weaver SP; Tweed E; Edgerton L Source: American Family Physician. 2008 Sep 1;78(5):634-5. Abstract: Clinical Question: Do antiepileptic drugs affect oral contraceptive effectiveness? Evidence-Based Answer: We found no studies that measure, or even estimate, any increase in pregnancy rates in women taking antiepileptic drugs. Antiepileptic drugs known to induce the hepatic cytochrome P450 (CYP450) isoenzyme cause decreased sex hormone levels in women taking oral contraceptives, raising the potential for decreased effectiveness of oral contraceptives and increased risk of unplanned pregnancy. (Strength of Recommendation [SOR]: C, based on small cohort studies). Antiepileptic drugs that do not induce this hepatic isoenzyme are not thought to compromise the effectiveness of oral contraceptives. (SOR: C, based on small cohort studies and randomized controlled trials). (excerpt) Language: English Keywords: UNITED STATES OF AMERICA | CRITIQUE | RECOMMENDATIONS | CLINICAL RESEARCH | WOMEN | DRUG INTERACTIONS | ORAL CONTRACEPTIVES | ORAL CONTRACEPTIVES, LOW-DOSE | CONTRACEPTIVE EFFECTIVENESS | CENTRAL NERVOUS SYSTEM EFFECTS | ENZYMATIC EFFECTS | CONTRACEPTIVE AGENTS, ESTROGEN | ADMINISTRATION AND DOSAGE | ORAL CONTRACEPTIVES, CONTRAINDICATIONS | Developed Countries | North America | Americas | Research Methodology | Demographic Factors | Population | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Contraceptive Methods | Contraception | Family Planning | Central Nervous System | Physiology | Biology | Enzymes and Enzyme Inhibitors | Contraceptive Agents, Female | Contraceptive Agents | Contraceptive Safety | Safety | Public Health Document Number: 328504 |
| 16. Title: The latest advances in hormonal contraception. Author: Fontenot HB; Harris AL Source: Journal of Obstetric, Gynecologic, and Neonatal Nursing. 2008 May-Jun;37(3):369-374. Abstract: Millions of women each year start or continue to use some type of hormonal contraceptive method. Choosing a method may be anxiety provoking. In this article, we review some of the latest advances in and options for hormonal contraception, including extended-dose oral contraceptives, the vaginal ring, injectable methods, and emergency contraception. Nurses can facilitate women's decision making for healthy reproductive options. (author's) Language: English Keywords: GLOBAL | RESEARCH REPORT | LITERATURE REVIEW | CONTRACEPTIVE AGENTS, FEMALE | CONTRACEPTIVE AGENTS, ESTROGEN | CONTRACEPTIVE AGENTS, PROGESTIN | ORAL CONTRACEPTIVES | ORAL CONTRACEPTIVES, LOW-DOSE | VAGINAL RING | EMERGENCY CONTRACEPTION | INJECTABLES | DEPO-PROVERA | ORAL CONTRACEPTIVES, CONTRAINDICATIONS | ORAL CONTRACEPTIVES, SIDE EFFECTS | CONTRACEPTIVE AGENTS, SIDE EFFECTS | Contraceptive Agents | Contraception | Family Planning | Contraceptive Methods | Medroxyprogesterone Acetate | Contraceptive Safety | Safety | Public Health | Health Document Number: 326908 |
| 17. Peer Reviewed Title: Effects of two low-dose combined oral contraceptives containing drospirenone on bone turnover and bone mineral density in young fertile women: a prospective controlled randomized study. Author: Gargano V; Massaro M; Morra I; Formisano C; Di Carlo C Source: Contraception. 2008 Jul;78(1):10-15. Abstract: Background: The effects of a 21-day combined oral contraceptive containing 30 mcg ethinyl estradiol plus 3 mg drospirenone with a 21-day preparation containing 20 mcg ethinyl estradiol plus 3 mg drospirenone on bone turnover and bone mineral density (BMD) in young fertile women were compared. Methods: A randomized, controlled trial was conducted on healthy fertile women treated with 30 mcg ethinyl estradiol plus 3 mg drospirenone (Group A; n=21), 20 mcg ethinyl estradiol plus 3 mg drospirenone (Group B; n=23) and healthy controls (Group C; n=21). At 3, 6, 9 and 12 months, serum and urinary calcium, osteocalcin (BGP), urinary pyridinoline and deoxypyridinoline were measured. At baseline and after 12 months, lumbar bone mineral density was determined by dual-energy X-ray absorptiometry. Results: In Groups A and B, urinary pyridinoline and deoxypyridinoline at 6, 9 and 12 months were significantly reduced in comparison with basal values and Group C (p<.05). In Groups A and B, serum calcium levels were significantly increased after 6 months. No significant difference was detected between Groups A and B in urinary levels of pyridinoline and deoxypyridinoline, in calcium levels and in BGP levels. At 12 months, no significant difference was detected in spinal BMD values between the three groups and in comparison with basal values. Conclusion: Both combined oral contraceptives exert a similar positive influence on bone turnover in young postadolescent women. (author's) Language: English Keywords: ITALY | ORAL CONTRACEPTIVES, LOW-DOSE | ORAL CONTRACEPTIVES, COMBINED | ETHINYL ESTRADIOL | CONTROL GROUPS | SKELETAL EFFECTS | Developed Countries | Europe, Southern | Europe | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Contraceptive Agents, Estrogen | Contraceptive Agents, Female | Contraceptive Agents | Research Methodology | Physiology | Biology Document Number: 327345 |
| 18. Title: Progestin and breast cancer. The missing pieces of a puzzle. Author: Giersig C Source: Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz. 2008 Jul;51(7):782-6. Abstract: The previous assumption that progestin does not promote breast cancer development needs to be re-examined since a growing body of evidence indicates the opposite. Data from recent experimental trials and results from clinical and epidemiological studies on hormonal contraceptives and hormone replacement therapy (HRT) have been confronted with breast cancer cases known from the German database of adverse drug reactions (ADR), reported in association with the use of progestin only contraceptives (POC) and combined oral contraceptives (COC). Also cases reported in association with HRT have been analysed. The available data complement one another showing a tumour promoting potential of progestin, possibly higher than that of a combination of estrogen and progestin. These assumptions are based on the following facts: 1) in estrogen-supplemented animals, progesterone has been shown to reactivate the growth of regressed tumour xenograft obtained from breast cancer cell lines, expressing both estrogen andprogesterone receptor; 2) antiprogestin has been revealed to suppress the reactivation of the growth of tumour xenograft and to fully suppress the development of breast cancer in an animal model for BRCA1 gene mutation; 3) metabolites of progesterone have been recognised as potent regulators of cell proliferation, cell detachment and apoptosis; 4) progesterone has been shown to inhibit, in a dose-dependent manner, apoptosis in breast cancer cell lines and apoptosis induced by doxorubicin and 5-fluorouracyl (drugs used in breast cancer treatment); 5) an association between breast cancer and HRT was suspected upon the addition of progestin on a regular basis for the prevention of endometrial cancer; 6) in a randomised placebo-controlled trial on HRT an increased risk of breast cancer was shown for the combination of estrogen and progestin, but not for estrogen alone; 7) in epidemiological studies on POC the recognition of an increased breast cancer risk was most probably impeded due to previously unrecognised systematic selection bias; 8) in a large epidemiological study on the risk of early-onset breast cancer in association with COC an increased risk was detected for COC use up to 1975, but no increased, even a slightly decreased, risk was shown for users of low-dose COC, applied since 1976; 9) a considerably higher number of breast cancer cases have been reported from Germany on POC than on the widespread used COC [corrected] (111 versus 12); 10) the big resemblance among the breast cancers reported for POC and their similarity with breast malignancies diagnosed in pregnancy suggest the existence of a pattern rather than pure coincidence [corrected] Language: English Keywords: GLOBAL | SUMMARY REPORT | EPIDEMIOLOGY | CLINICAL RESEARCH | LABORATORY ANIMALS | HORMONE REPLACEMENT THERAPY | ESTROGENS | ORAL CONTRACEPTIVES, LOW-DOSE | BREAST CANCER | CONTRACEPTIVE AGENTS, PROGESTIN | Public Health | Health | Research Methodology | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Hormones | Endocrine System | Physiology | Biology | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Cancer | Neoplasms | Diseases | Contraceptive Agents, Female | Contraceptive Agents Document Number: 328638 |
| 19. Title: Effect of reproductive factors and oral contraceptives on breast cancer risk in BRCA1/2 mutation carriers and noncarriers: results from a population-based study. Author: Lee E; Ma H; McKean-Cowdin R; Van Den Berg D; Bernstein L; Henderson BE; Ursin G Source: Cancer Epidemiology, Biomarkers and Prevention. 2008 Nov;17(11):3170-8. Abstract: BACKGROUND: Multiparity and breast-feeding reduce breast cancer risk, whereas oral contraceptive use may slightly increase breast cancer risk in the general population. However, the effects of these factors in BRCA1 and BRCA2 mutation carriers are less clear. METHODS: Case patients were 1,469 women from Los Angeles County ages 20 to 49 years with newly diagnosed breast cancer. Control subjects were 444 women without breast cancer, individually matched to a subset of cases on race, age, and neighborhood. BRCA1/2 genes were sequenced in the cases, and odds ratios of breast cancer associated with various reproductive and hormonal factors in BRCA1/2 mutation carriers and noncarriers were estimated using multivariable logistic regression. RESULTS: Ninety-four women had a deleterious BRCA1 or BRCA2 mutation. Number of full-term pregnancies was inversely associated with breast cancer risk regardless of BRCA1/2 mutation status. Longer breast-feeding duration was protective among noncarriers but not among mutation carriers; however, this apparent effect modification was not statistically significant (P = 0.23). Neither oral contraceptive use overall nor the use of low-dose oral contraceptives was associated with an increased risk of breast cancer in any subgroup. CONCLUSIONS: Our results suggest that parity protects against breast cancer in BRCA1/2 mutation carriers, whereas breast-feeding does not. Our data suggest no association between oral contraceptive use and breast cancer risk in BRCA1/2 mutation carriers. Further confirmation that currently available low-dose oral contraceptives do not increase breast cancer risk in carriers is important from a public health perspective given the high prevalence of oral contraceptive use in the United States. Language: English Keywords: UNITED STATES OF AMERICA | CALIFORNIA | RESEARCH REPORT | CASE STUDIES | WOMEN | MULTIPARITY | BREAST CANCER | ORAL CONTRACEPTIVES, LOW-DOSE | Developed Countries | North America | Americas | Studies | Research Methodology | Demographic Factors | Population | Parity | Fertility Measurements | Fertility | Population Dynamics | Cancer | Neoplasms | Diseases | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning Document Number: 330082 |
| 20. Title: Risk factors of cardiovascular disease among the oral contraceptive users in Kermanshah City of Iran [letter] Author: Malek-Khosravi S Source: JPMA. Journal of the Pakistan Medical Association. 2008 Aug;58(8):473-4. Abstract: This letter to the editor discusses risk factors associated with oral contraceptive use in Kermanshah City of Iran. It recommends a new generation oral contraceptive (OCP) with fewer side effects and attentiveness to the cardiovascular risk factors when prescribing OCPs. Language: English Keywords: IRAN | RESEARCH REPORT | CLINICAL RESEARCH | WOMEN IN DEVELOPMENT | ORAL CONTRACEPTIVES, SIDE EFFECTS | ORAL CONTRACEPTIVES, CONTRAINDICATIONS | RISK FACTORS | PROGESTERONE | ORAL CONTRACEPTIVES, COMBINED | ORAL CONTRACEPTIVES, LOW-DOSE | TIME FACTORS | AGE FACTORS | CARDIOVASCULAR EFFECTS | HYPERTENSION | Middle East | Developing Countries | Research Methodology | Economic Development | Economic Factors | Contraceptive Safety | Safety | Public Health | Health | Biology | Progestational Hormones | Hormones | Endocrine System | Physiology | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Population Dynamics | Demographic Factors | Population | Population Characteristics | Vascular Diseases | Diseases Document Number: 329155 |
| 21. Title: Oral contraceptive pretreatment and half dose of ganirelix does not excessively suppress LH and may be an excellent choice for scheduling IUI cycles. Author: Meldrum DR; Cassidenti DL; Rosen GF; Yee B; Wisot AL Source: Journal of Assisted Reproduction and Genetics. 2008 Aug;25(8):417-20. Abstract: PURPOSE: To assess the effects of using a reduced dose of ganirelix with oral contraceptive pretreatment in a pilot study of COH using pure FSH for intrauterine insemination (IUI) METHODS: Patients received oral contraceptive (OC; 30 microg ethinyl estradiol/150 microg desogestrel) for 14-21 days and rFSH (50-225 IU/day SC) was started on day 4 after OC discontinuation. Ganirelix acetate (125 microg/day) was started with a lead follicle diameter of 14 mm. RESULTS: Of the 25 subjects who started oral contraceptives, one was cancelled due to an excessive response, and one subject was not included in the analysis because she did not receive ganirelix until the lead follicle was 18 mm. Median (range) starting FSH dose was 100 (50-225), cumulative rFSH dose was 1000 (675-2175) IU over 10 (9-17) days. Duration of ganirelix acetate treatment was 4.0 (2-5) days. Seven subjects (30.4%) delivered ten babies (three pregnancies were twins). There were no biochemical pregnancies or miscarriages. Of the 16 subjects with measurement of LH on the day of HCG administration, only one was under 0.5 mIU/ml (0.4), and only one was over 10 mIU/ml (17.7), and that subject delivered twins. CONCLUSION: OC pretreatment afforded flexibility in scheduling while a reduced dose of ganirelix avoided excessive suppression of LH. The excellent results in this pilot study for IUI suggest this regimen could be further evaluated for scheduling IUI and IVF cycles. Language: English Keywords: MOZAMBIQUE | RESEARCH REPORT | CLINICAL RESEARCH | PILOT PROJECTS | WOMEN | ORAL CONTRACEPTIVES, COMBINED | ARTIFICIAL INSEMINATION | ORAL CONTRACEPTIVES, LOW-DOSE | ADMINISTRATION AND DOSAGE | ETHINYL ESTRADIOL | FOLLICLE STIMULATING HORMONE | IN VITRO | TIME FACTORS | Africa, Southern | Africa, Sub Saharan | Africa | Developing Countries | Research Methodology | Studies | Demographic Factors | Population | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Reproductive Technologies | Reproduction | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Contraceptive Agents, Estrogen | Contraceptive Agents, Female | Contraceptive Agents | Gonadotropins, Pituitary | Gonadotropins | Hormones | Endocrine System | Physiology | Biology | Population Dynamics Document Number: 329209 |
| 22. Peer Reviewed Title: YAZ and the novel progestin drospirenone. Author: Mishell DR Jr Source: Journal of Reproductive Medicine. 2008 Sep;53(9 Suppl):721-8. Abstract: Drospirenone is a novel progestin that is structurally related to 17 alpha-spirolactone and has antimineralocorticoid and antiandrogenic activity. A 3-mg dose of drospirenone was first used in combination with ethinyl estradiol (EE) 30 microg in a combination oral contraceptive (COC) that is administered for 21 days, followed by a 7-day hormone-free interval (HFI) (drospirenone/30EE, or Yasmin). The 21/7 regimen is considered to be the standard regimen for COC delivery. A formulation with the metabolic benefit of COCs containing a lower estrogen dose has been developed combining drospirenone 3 mg with EE 20 microg and using a regimen of 24 days of active pills, followed by a 4-day HFI (drospirenone/20EE-24/4), or YAZ (Bayer HealthCare Pharmaceuticals Inc., Wayne, New Jersey). Since drospirenone has a half-life of > 30 hours, its activity extends for a prolonged time into the shortened HFI. This new COC has been shown to provide effective contraception and to have a good safety profile. Two large noninterventional studies have recently evaluated the safety of drospirenone/30EE in 2 areas of special interest: hyperkalemia and thromboembolic events. Use of a drospirenone-containing COC was not associated with an increased risk of either type of disorder in comparison with COCs containing other progestins. Drospirenone/20EE-24/4 provides a low dose of EE in combination with drospirenone in an effective and safe COC that is administered using a regimen with a shortened HFI. Drospirenone/20EE-24/4 is the only COC with 3 indications: contraception and the treatment of premenstrual dysphoric disorder in women who wish to use a COC for birth control, and the treatment of moderate acne in women who are at least 14-years-old, have achieved menarche and wish to use a COC for birth control. Language: English Keywords: UNITED STATES OF AMERICA | LITERATURE REVIEW | CLINICAL RESEARCH | WOMEN | LOW-DOSE PROGESTINS | ORAL CONTRACEPTIVES, COMBINED | ORAL CONTRACEPTIVES, LOW-DOSE | ACNE | ORAL CONTRACEPTIVES, SIDE EFFECTS | TIME FACTORS | METABOLIC EFFECTS | CONTRACEPTIVE MODE OF ACTION | PREMENSTRUAL TENSION | CONTRACEPTIVE SAFETY | CONTRACEPTIVE EFFECTIVENESS | Developed Countries | North America | Americas | Research Methodology | Demographic Factors | Population | Contraceptive Agents, Progestin | Contraceptive Agents, Female | Contraceptive Agents | Contraception | Family Planning | Oral Contraceptives | Contraceptive Methods | Dermatitis | Diseases | Safety | Public Health | Health | Population Dynamics | Physiology | Biology | Menstruation Disorders Document Number: 329799 |
| 23. Peer Reviewed Title: Efficacy and safety of a 28-day oral contraceptive with 7 days of low-dose estrogen in place of placebo. Author: Poindexter A; Reape KZ; Hait H Source: Contraception. 2008 Aug;78(2):113-119. Abstract: The study was conducted to evaluate the efficacy and safety for the prevention of pregnancy of a 28-day oral contraceptive (OC) containing 150 mcg desogestrel (DSG)/20 mcg ethinyl estradiol (EE) for 21 days followed by 7 days of 10 mcg EE (Cette-28). A 6-month, prospective, multicenter, single-arm study was conducted in 1302 women aged 18-45 years. Over six cycles of treatment, the cumulative risk of pregnancy among all treated subjects (n=1262) was 0.9%. The Pearl Index for women 18-35 years of age (n=1042) was 2.20, including 9 pregnancies with estimated conception dates during active drug ingestion or up to 7 days after the last combination tablet. The rate of unscheduled bleeding was low and the duration of scheduled bleeding was approximately 2 days during each of the six treatment cycles. The safety profile was similar to what has been reported for other OCs. This low-dose, 28-day OC incorporating 7 days of 10 mcg EE during the hormone free interval is effective and safe for the prevention of pregnancy and is well-tolerated by women. (author's) Language: English Keywords: UNITED STATES OF AMERICA | RESEARCH REPORT | CLINICAL TRIALS | ORAL CONTRACEPTIVES, LOW-DOSE | CONTRACEPTIVE SAFETY | ORAL CONTRACEPTIVES, SIDE EFFECTS | CONTRACEPTIVE EFFECTIVENESS | Developed Countries | North America | Americas | Clinical Research | Research Methodology | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Safety | Public Health | Health Document Number: 327963 |
| 24. Title: Pharmacokinetic interaction between ethinyl estradiol, norethindrone and darunavir with low-dose ritonavir in healthy women. Author: Sekar VJ; Lefebvre E; Guzman SS; Felicione E; De Pauw M; Vangeneugden T; Hoetelmans RM Source: Antiviral Therapy. 2008;13(4):563-9. Abstract: BACKGROUND: An open-label, randomized, crossover study was performed to investigate the effect of multiple doses of darunavir co-administered with low-dose ritonavir (DRV/r) on the steady-state pharmacokinetics of the oral contraceptives ethinyl estradiol (EE) and norethindrone (NE) (commercial name of the combined drug Ortho-Novum 1/35) in 19 HIV-negative healthy women. METHODS: In session 1, participants received 35 microg EE and 1.0 mg NE from days 1 to 21. In session 2, participants received the same oral contraceptive treatment as in session 1 on days 1 to 21 plus DRV/r (600 mg/100 mg twice daily) on days 1 to 14. Pharmacokinetic assessments were performed on day 14 for each session. RESULTS: Steady-state systemic exposure to EE and NE decreased when DRV/r was co-administered, based on the ratio of least square means of the minimum plasma concentration (Cmin), the maximum plasma concentration (Cmax), and the area under the curve (AUC24h) of EE (which decreased by 62%, 32% and 44%, respectively) and NE (which decreased by 30%, 10% and 14%, respectively) compared with administration of EE and NE alone. Five participants discontinued the study due to grade 2 cutaneous events, as required per protocol, during treatment with EE and NE in combination with DRV/r. There were no clinically relevant findings for laboratory and cardiovascular parameters. CONCLUSIONS: The pharmacokinetic interaction observed here is considered to be clinically relevant as EE concentrations are considerably reduced when DRV/r is co-administered with EE and NE. Alternative or additional contraceptive measures should be used when oestrogen-based contraceptives are co-administered with DRV/r. Language: English Keywords: BELGIUM | RESEARCH REPORT | CLINICAL RESEARCH | WOMEN | ETHINYL ESTRADIOL | ORAL CONTRACEPTIVES, LOW-DOSE | ADMINISTRATION AND DOSAGE | DRUG INTERACTIONS | CONTRACEPTION TERMINATION | DERMATOLOGICAL EFFECTS | ORAL CONTRACEPTIVES, SIDE EFFECTS | CONTRACEPTIVE SAFETY | ORAL CONTRACEPTIVES, COMBINED | Developed Countries | Europe, Western | Europe | Research Methodology | Demographic Factors | Population | Contraceptive Agents, Estrogen | Contraceptive Agents, Female | Contraceptive Agents | Contraception | Family Planning | Oral Contraceptives | Contraceptive Methods | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Physiology | Biology | Safety | Public Health Document Number: 328734 |
| 25. Title: Extended- and continuous-cycle oral contraceptives. Author: Shrader SP; Dickerson LM Source: Pharmacotherapy. 2008 Aug;28(8):1033-40. Abstract: Five new oral contraceptives, classified as extended- or continuous-cycle oral contraceptives, have been approved by the United States Food and Drug Administration. These agents have various combinations of estrogen and progestin, and different effects on the length of women's menstrual cycles. Usually they shorten the duration of menses, decrease the frequency of menses to 4 times/year, or completely eliminate menses. These new oral contraceptives are given in the following regimens: 24 days followed by placebo for 4 days (24/4), 84 days followed by placebo for 7 days (84/7), or continuously (without placebo). These agents contain ethinyl estradiol 20 microg-drospirenone 3 mg (24/4); ethinyl estradiol 20 microg-norethindrone 1 mg (24/4); ethinyl estradiol 30 microg-levonorgestrel 150 microg (84/7); ethinyl estradiol 30 microg-levonorgestrel 150 microg (84/7) with very low-dose ethinyl estradiol (10 microg/day) for 7 days; and ethinyl estradiol 20 microg-levonorgestrel 90 microg continuously. Clinical trials have demonstrated that extended- and continuous-cycle oral contraceptives are as effective in preventing pregnancy as traditional oral contraceptives. These new agents also have similar adverse effects; however, the only significantly different adverse effect compared with traditional oral contraceptives in clinical trials was change in bleeding pattern. These oral contraceptives are associated with more breakthrough bleeding and spotting than the traditional pills. Long-term effects on efficacy and safety are not known, as these new products generally have been used for only 1-2 years. Extended- and continuous-cycle oral contraceptives are a new option for women desiring decreased menses or for whom decreased menses may alleviate symptoms of coexisting medical conditions. Language: English Keywords: UNITED STATES OF AMERICA | LITERATURE REVIEW | CLINICAL RESEARCH | WOMEN | ORAL CONTRACEPTIVES, COMBINED | USFDA | PRODUCT APPROVAL | TIME FACTORS | ETHINYL ESTRADIOL | ADMINISTRATION AND DOSAGE | ORAL CONTRACEPTIVES, LOW-DOSE | LEVONORGESTREL | SIDE EFFECTS | CONTRACEPTIVE SAFETY | LONGTERM EFFECTS | Developed Countries | North America | Americas | Research Methodology | Demographic Factors | Population | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | USPHS | Government Agencies | Organizations | Political Factors | Sociocultural Factors | Legislation | Population Dynamics | Contraceptive Agents, Estrogen | Contraceptive Agents, Female | Contraceptive Agents | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Contraceptive Agents, Progestin | Safety | Public Health Document Number: 329241 |
| 26. Peer Reviewed Title: Continuous oral contraception: Changing times. Author: Sulak PJ Source: Best Practice and Research Clinical Obstetrics and Gynaecology. 2008 Apr;22(2):355-374. Abstract: Oral contraceptives (OCs) remain the most common method of reversible contraception. Despite lowering of oestrogen and progestin content, the same basic design of 21 combination oestrogen plus progestin pills followed by a week of placebo pills has remained. Numerous studies have now documented that the 21/7 regimen needs to be modified. The 7-day hormone-free interval (HFI) in today's low-dose OCs is associated with reduced pituitary-ovarian suppression, allowing for ovarian follicular development, endogenous oestradiol production and possible ovarian cyst formation and ovulation. The 7-day HFI is also associated with hormone withdrawal symptoms that can lead to discontinuation and unintended pregnancy. Modifications in OC regimens are now appearing on the market secondary to the accumulated scientific data on the disadvantages of low-dose 21/7 pills. This article will review the data on problems with standard OC regimens and modifications that can improve the efficacy and side-effect profile. (author's) Language: English Keywords: UNITED STATES OF AMERICA | LITERATURE REVIEW | CLINICAL RESEARCH | WOMEN | ORAL CONTRACEPTIVES, COMBINED | CONTRACEPTIVE AGENTS, ESTROGEN | ORAL CONTRACEPTIVES, LOW-DOSE | PITUITARY GLAND | FOLLICLE STIMULATING HORMONE | ADMINISTRATION AND DOSAGE | Developed Countries | North America | Americas | Research Methodology | Demographic Factors | Population | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Contraceptive Agents, Female | Contraceptive Agents | Endocrine System | Physiology | Biology | Gonadotropins, Pituitary | Gonadotropins | Hormones | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health Document Number: 324955 |
| 27. Title: Changes in blood pressure, BMI and ECG patterns in women using low-dose contraceptives. Author: Syed S; Rahim M; Javed M; Qureshi MA Source: Journal of the College of Physicians and Surgeons, Pakistan. 2008 Jan;18(1):31-36. Abstract: The objective was to determine the cardiovascular risk factors in users of second generation contraceptives by recording changes in body mass index, blood pressure and electrocardiogram. The design of the study was cross-sectional study. The setting for the study was The National Institute of Fertility Research Centers at Jinnah Postgraduate Medical Center and PIB Maternity Home Karachi, from July 1997 to 1999. Sixty four women volunteered for this study (age range 20-35 years), belonging to low-income group with similar socio-cultural background. The Body Mass Index (BMI) was calculated by measuring height and weight of the subjects; systolic and diastolic blood pressure and ECG recording by standard method. The group means, standard deviations and coefficient correlation for interrelationship among variables in respective groups of subjects were calculated using relevant statistical method and software program. There was no significant difference between BMI of two types of contraceptive users as compared to non users; but BMI was significantly correlated with both systolic and diastolic blood pressures in injectable users as compared to controls. ECG alterations frequently observed in contraceptive users (40%) as compared to controls were normal findings. It was observed that women aged less than 30 years and using contraceptives for more than three years had a tendency to gain weight and developed a mild increase in systolic and diastolic blood pressures. (author's) Language: English Keywords: PAKISTAN | RESEARCH REPORT | CROSS SECTIONAL ANALYSIS | WOMEN | ORAL CONTRACEPTIVES, LOW-DOSE | INJECTABLES | CARDIOVASCULAR EFFECTS | BODY WEIGHT | BLOOD PRESSURE | Developing Countries | Asia, Southern | Asia | Research Methodology | Demographic Factors | Population | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Physiology | Biology | Hemic System Document Number: 324371 |
| 28. Title: Effect of two low-dose gestodene containing monophasic oral contraceptives on hemostasis in Bulgarian women. Author: Uchikova E; Pehlivanov B Source: Expert Opinion On Pharmacotherapy. 2008 Aug;9(11):1839-44. Abstract: OBJECTIVE: To compare the effects of two monophasic oral contraceptives upon coagulation, fibrinolysis and the system of natural inhibitors (anticoagulant pathways) in Bulgarian women. METHODS: This prospective, open clinical study lasted 12 months and included 70 women, divided into two equal groups of 35 each. The women from group A received a contraceptive containing 20 microg ethinylestradiol/75 microg gestodene. The women from group B received a contraceptive containing 30 microg ethinylestradio l/75 microg gestodene. At the beginning and again at the end of the study, the following values were determined: prothrombin time (PT), activated partial thromboplastic time (aPTT), thrombin time (TT), fibrinogen (F), Factor VII (FVII), Factor X (FX), plasminogen, alpha 2-antiplasmin, tissue-type plasminogen activator (t-PA), D-dimers, protein C (Pr C), total Protein S (TPr S), antithrombin III (AT III) and heparin Cofactor II (HC II). RESULTS: We did not find any statistically significant differences in the global tests of hemostasis (PT, aPTT, TT) in either group compared with the baseline values. At the end of the study there was an increase in the levels of fibrinogen, FX, PrC and H II, and also diminution of t-PA in both groups in comparison with the baseline values. At the end of the study the activity of FVII, alpha2-antiplasmin and AT III was elevated only in group B. Although certain alterations in hemostasis parameters were observed, all of them were within the reference range. We did not observe or suspect any cases of vascular, thrombotic or other incidence in the observed groups of 840 cycles of hormonal contraception over the 12-month period. CONCLUSION: There is an increase in both procoagulant and fibrinolytic activity when using low-dose gestodene containing monophasic oral contraceptives. This can be interpreted as a shift to a higher equilibrium. There is no need for screening for thrombofilia in healthy, non-obese, non-smoking Bulgarian females, aged between 18 to 35 years, without a personal or family history of thrombotic diseases, before starting on third generation oral contraceptive with gestodene. Language: English Keywords: BULGARIA | RESEARCH REPORT | COMPARATIVE STUDIES | WOMEN | CLIENTS | ETHINYL ESTRADIOL | GESTODENE | ORAL CONTRACEPTIVES | ORAL CONTRACEPTIVES, LOW-DOSE | ORAL CONTRACEPTIVES, SIDE EFFECTS | PROGRAM EFFECTIVENESS | Europe, Southeastern | Europe | Developing Countries | Studies | Research Methodology | Demographic Factors | Population | Program Activities | Programs | Organization and Administration | Contraceptive Agents, Estrogen | Contraceptive Agents, Female | Contraceptive Agents | Contraception | Family Planning | Contraceptive Agents, Progestin | Contraceptive Methods | Contraceptive Safety | Safety | Public Health | Health | Program Evaluation Document Number: 328306 |
| 29. Peer Reviewed Title: Contraceptive vaginal ring use for women has less adverse metabolic effects than an oral contraceptive. Author: Elkind-Hirsch KE; Darensbourg C; Ogden B; Ogden LF; Hindelang P Source: Contraception. 2007 Nov;76(5):348-356. Abstract: This study compared metabolic, hormonal and lipid profiles before and during use of a contraceptive vaginal ring (RING) releasing 15 mcg ethinyl estradiol (EE) and 120 mcg etonogestrel per day (NuvaRing, Organon USA Inc., Roseland, NJ) versus a low-dose oral contraceptive (PILL) containing 20 mcg EE and 100 mcg levonorgestrel daily (Aviane, Barr Pharmaceuticals Inc., Pomona, NY). Sixty-five women were randomized to either the RING or PILL treatment for five cycles. In the pretreatment cycle (Cycle Days 2-5) and during Weeks 2 and 3 of the fifth treatment cycle, a 75-g oral glucose tolerance test (OGTT) was performed. Baseline samples were used to evaluate basal hormonal, metabolic and lipid levels. Forty-two women completed the study. Basal insulin resistance (HOMA-IR) was slightly decreased, whereas a significant reduction in the insulin sensitivity index (ISOGTT) was found in women on PILL therapy compared to those in the RING group (p less than .035). Pancreatic beta-cell function was not significantly altered with either treatment. The lower-dose, nonoral hormonal RING had a lesser impact on carbohydrate metabolism and greater reduction of free androgen and dehydroepiandrosterone sulfate levels than PILL treatment. (author's) Language: English Keywords: UNITED STATES OF AMERICA | RESEARCH REPORT | CLINICAL RESEARCH | COMPARATIVE STUDIES | PROSPECTIVE STUDIES | WOMEN | ORAL CONTRACEPTIVES, LOW-DOSE | VAGINAL RING | TREATMENT | CARBOHYDRATE METABOLIC EFFECTS | Developed Countries | North America | Americas | Research Methodology | Studies | Demographic Factors | Population | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Metabolic Effects | Physiology | Biology Document Number: 321663 |
| 30. Title: Effect of a low-dose oral contraceptive on venous endothelial function in healthy young women: Preliminary results. Author: Giribela CR; Rubira MC; de Melo NR; Plentz RD; de Angelis K Source: Clinics. 2007;62(2):151-158. Abstract: A possible increase in the incidence of venous thromboembolic events has been reported among users of third generation oral contraceptives. The objective of this study was to evaluate the effect of a low dose oral contraceptive (15 µg ethinyl estradiol/60 µg gestodene) on the venous endothelial function of healthy young women. Prospective case control study using the dorsal hand vein technique. Venous endothelial function was evaluated at baseline and after 4 months in the oral contraceptive users group (11 women) and in a control group (9 women). After preconstriction of the vein with phenylephrine, dose-response curves for acetylcholine and sodium nitroprusside were constructed. In the contraceptive users group, a reduction occurred in the maximum venodilation response to acetylcholine and sodium nitroprusside after 4 months of oral contraceptive use, but this difference was not statistically significant (P > 0.05). No significant changes were detected in maximum venodilation responses to acetylcholine and sodium nitroprusside at the 4-month time point in the control group. This study found no significant impairment of endothelium-dependent or independent venodilation in healthy young women following oral contraceptive use. Further studies are necessary using the same methodology in a larger sample over a longer follow-up period. (author's) Language: English Keywords: BRAZIL | RESEARCH REPORT | CASE CONTROL STUDIES | WOMEN | YOUTH | ORAL CONTRACEPTIVES, LOW-DOSE | ORAL CONTRACEPTIVES, SIDE EFFECTS | HEMATOLOGICAL EFFECTS | THROMBOEMBOLISM | South America, Eastern | South America | Latin America | Americas | Developing Countries | Studies | Research Methodology | Demographic Factors | Population | Age Factors | Population Characteristics | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Contraceptive Safety | Safety | Public Health | Health | Hemic System | Physiology | Biology | Embolism | Vascular Diseases | Diseases Document Number: 320496 |
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