1.  Peer Reviewed Title: Evaluation of mifepristone as a once a month contraceptive pill. Author: Agarwal M; Das V; Agarwal A; Pandey A; Srivastava D Source: American Journal of Obstetrics and Gynecology. 2009 May;200(5):e27-9. Abstract: OBJECTIVE: The purpose of this study was to assess the efficacy and safety of mifepristone as a contraceptive pill. STUDY DESIGN: A prospective case-control study was conducted in a tertiary care center of North India. The study group (n = 86) was given 200-mg mifepristone tablets on the 16th day of the menstrual cycle. The control group (n = 92) received combined oral contraceptive (COC) as per protocol. Subjects were followed for drug compliance, satisfaction, side effects, and failure. RESULTS: Acceptability of mifepristone was significantly higher in educated population (P < .001), with fewer side effects (P = .001), good satisfaction (P < .001), and higher compliance rate (P = .05). The oral contraceptive pill group had higher adverse biochemical parameters. CONCLUSION: Mifepristone can be used as a monthly contraceptive pill effectively. Language: English Keywords: INDIA | RESEARCH REPORT | ORAL CONTRACEPTIVES | RU-486 | TIME FACTORS | ADMINISTRATION AND DOSAGE | Asia, Southern | Asia | Developing Countries | Contraceptive Methods | Contraception | Family Planning | Hormone Antagonists | Hormones | Endocrine System | Physiology | Biology | Population Dynamics | Demographic Factors | Population | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health Document Number: 341243 |
| 2. Title: Misoprostol for pregnancy termination in grand multiparous women with three cesarean deliveries. Author: Alsibiani SA Source: International Journal of Gynaecology and Obstetrics. 2009 Apr 3; Abstract: In countries in which women have high parity, pregnancy termination is common in women who have had multiple cesarean deliveries. Although a combination of mifepristone and misoprostol is recommended for late abortion, in Saudi Arabia, mifepristone is not approved or available. There is little information about the safety of misoprostol for the termination of pregnancy or induction of labor in women with scarred uteri and multiple cesarean deliveries. Although there is no recommended dose or mode of administration for misoprostol in patients with scarred uteri and high parity, it is advisable to use a low dose. Misoprostol use in women with scarred uteri can lead to uterine rupture, but few incidences have been reported in the literature. However, caution is advisable. Misoprostol administered orally has a rapid onset of action and increases uterine tone, but contractions are not experienced unless repeated doses are administered. In addition, women usually prefer oral administration. Vaginal administration offers prolonged activity, greatest bioavailability, and a lower incidence of adverse effects. Use of misoprostol for termination of pregnancy in 2 grand multiparous (gravidity N10) women each with 3 previous cesarean deliveries is summarized in Table 1. According to the WHO expert dosage guidelines, the maximum dose was not exceeded in either patient. In patient 1 an intracervical Foley catheter with syntocinon infusion was used to ripen the cervix followed by oral administration of 800 µg of misoprostol. Patient 2 received a single dose of 800 µg of misoprostol vaginally. Favorable results were obtained in both women using a single high dose of misoprostol. The safety of using misoprostol in women with high parity and scarred uteri could not be ascertained from this study. A larger study is needed to confirm the effectiveness and safety of this regimen in patients with high parity who have had more than 2 previous cesarean deliveries. (full-text) Language: English Keywords: SAUDI ARABIA | RESEARCH REPORT | SUMMARY REPORT | CLINICAL RESEARCH | PREGNANT WOMEN | CESAREAN SECTION | ABORTION | MULTIPARITY | MISOPROSTOL | UTERUS | RU-486 | ADMINISTRATION AND DOSAGE | Middle East | Developing Countries | Research Methodology | Population Characteristics | Demographic Factors | Population | Obstetrical Surgery | Surgery | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Fertility Control, Postconception | Family Planning | Parity | Fertility Measurements | Fertility | Population Dynamics | Prostaglandins, Synthetic | Prostaglandins | Endocrine System | Physiology | Biology | Genitalia, Female | Genitalia | Urogenital System | Hormone Antagonists | Hormones | Drugs Document Number: 341466 |
| 3. Title: Oral Contraceptives: A Risk Factor for Squamous Cell Carcinoma? Author: Applebaum KM; Nelson HH; Zens MS; Stukel TA; Spencer SK; Karagas MR Source: Journal of Investigative Dermatology. 2009 Jun 25; Abstract: Oral contraceptives (OCs) affect the risk of several cancers in women, but have been virtually unstudied for squamous cell carcinoma (SCC). We examined the hypothesis that OCs influence SCC risk in a case-control study among women and also examined whether polymorphisms in the DNA repair gene, Xeroderma pigmentosum group D (XPD), modified the risk. Incident cases of SCC were identified by a network of dermatologists and pathology laboratories. Population-based controls were frequency matched to cases by age and gender (n=261 SCC cases, 298 controls). Overall, OC use was associated with a 60% higher risk of SCC (odds ratio (OR), 1.6; 95% confidence interval (95% CI): 1.0-2.5). ORs for SCC were higher among those who last used OCs >/=25 years before diagnosis (OR: 2.1; 95% CI: 1.2-3.7), and among these women, SCC risk increased with duration of use (OR for /=7 years, 2.7; 95% CI: 0.9-8.5, P(trend)=0.01). Furthermore, the XPD Lys751Gln polymorphism was a significant modifier of the OC-SCC association (P(interaction)=0.03). These findings lead us to hypothesize a potential relationship between OCs and SCC risk, and that this could involve DNA repair pathways.Journal of Investigative Dermatology advance online publication, 25 June 2009; doi:10.1038/jid.2009.168. Language: English Keywords: UNITED STATES OF AMERICA | NEW HAMPSHIRE | RESEARCH REPORT | CONTROL GROUPS | WOMEN | ORAL CONTRACEPTIVES | CONTRACEPTIVE AGENTS, SIDE EFFECTS | RISK FACTORS | CANCER | DERMATOLOGICAL EFFECTS | ESTROGENS | Developed Countries | North America | Americas | Research Methodology | Demographic Factors | Population | Contraceptive Methods | Contraception | Family Planning | Contraceptive Agents | Health | Neoplasms | Diseases | Physiology | Biology | Hormones | Endocrine System Document Number: 341751 |
| 4. Title: Emergency contraception: how does it work? Author: Baird DT Source: Reproductive Biomedicine Online. 2009;18 Suppl 1:32-6. Abstract: Emergency (or post-coital) contraception is any substance or device that is used to prevent pregnancy after unprotected intercourse. Currently used hormonal methods of emergency contraception (high-dose combined oral contraceptive pill or levonorgestrel) prevent about 50-80% of pregnancies. Research has demonstrated that these methods inhibit the midcycle surge of LH from the pituitary and, if given at least 2 days before ovulation, ovulation is delayed or prevented. Ovulation still occurs if administration is delayed until ovulation is imminent. Biological data that suggest that the most likely mode of action is by preventing fertilization are supported by the clinical observation that the greater the interval between coitus and administration the greater the chance of pregnancy. There are no data supporting the view that levonorgestrel can impair the development of the embryo or prevent implantation. In contrast, other very effective methods of emergency contraception, such as mifepristone and intrauterine devices, can also inhibit implantation. Language: English Keywords: UNITED KINGDOM | RESEARCH REPORT | EMERGENCY CONTRACEPTION | IUD | RU-486 | LEVONORGESTREL | CONTRACEPTIVE EFFECTIVENESS | Developed Countries | Europe, Western | Europe | Contraception | Family Planning | Contraceptive Methods | Hormone Antagonists | Hormones | Endocrine System | Physiology | Biology | Contraceptive Agents, Progestin | Contraceptive Agents, Female | Contraceptive Agents Document Number: 330739 |
| 5. Peer Reviewed Title: Medication abortion. Author: Bartz D; Goldberg A Source: Clinical Obstetrics and Gynecology. 2009 Jun;52(2):140-50. Abstract: Medical methods for pregnancy termination in early gestation offer women an alternative to surgical evacuation and have the potential to improve access globally to safe abortion. Several drug regimens are used with varying efficacy including mifepristone plus misoprostol, misoprostol alone, and methotrexate plus misoprostol. Where available, a mifepristone plus misoprostol regimen is most frequently used and is highly effective for early abortion. We review these drug regimens along with clinical practice recommendations including patient counseling and selection, regimen administration location, expected side effects, and follow-up procedures. Overall, women who choose medical abortion report high levels of satisfaction. Language: English Keywords: UNITED STATES OF AMERICA | MASSACHUSETTS | RESEARCH REPORT | ABORTION | MISOPROSTOL | RU-486 | DRUGS | COUNSELING | Developed Countries | North America | Americas | Fertility Control, Postconception | Family Planning | Prostaglandins, Synthetic | Prostaglandins | Endocrine System | Physiology | Biology | Hormone Antagonists | Hormones | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Clinic Activities | Program Activities | Programs | Organization and Administration Document Number: 342250 Notification |
| 6. Title: Quantitative analysis of DHEA and androsterone in female urine: investigating the effects of menstrual cycle, oral contraception and training on exercise-induced changes in young women. Author: Bayle ML; Enea C; Goetinck P; Lafay F; Boisseau N; Dugue B; Flament-Waton MM; Grenier-Loustalot MF Source: Analytical and Bioanalytical Chemistry. 2009 Feb;393(4):1315-25. Abstract: Dehydroepiandrosterone (DHEA) and its metabolite androsterone (A) are natural steroids secreted in high quantities in human body. To assess the influence of oral contraceptives, menstrual cycle phase, and also physical exercise (acute and chronic such as training) on these metabolites excretions, a collection of 28 female urine specimens was organized. A three-extraction-step method was developed, and the analyses were performed by gas chromatography-mass spectrometry using deuterated 19-noretiocholanolone as the internal standard. Sample hydration state was found to be of great importance for kinetic studies, as it directly influenced the concentrations. No influence of menstrual cycle and training was found for androsterone and DHEA. However, oral contraceptive intake lowered DHEA excretion in urine and A seems to be slightly affected by exercise. Language: English Keywords: FRANCE | RESEARCH REPORT | CLINICAL RESEARCH | WOMEN | ATHLETES | MENSTRUAL CYCLE | ORAL CONTRACEPTIVES | FITNESS | DEHYDROEPIANDROSTERONE | ANALYSIS | LABORATORY EXAMINATIONS AND DIAGNOSES | PHYSIOLOGY | Developed Countries | Europe, Western | Europe | Research Methodology | Demographic Factors | Population | Population Characteristics | Menstruation | Reproduction | Contraceptive Methods | Contraception | Family Planning | Health | Androgens | Hormones | Endocrine System | Biology | Examinations and Diagnoses | Medical Procedures | Medicine | Health Services | Delivery of Health Care Document Number: 330963 |
| 7. Title: Genetic counseling for teratogenic risk due to exposure to medications: 89 pregnancies conceived during oral contraceptive use. Author: Belli S; Mazzola S; Luongo R; Barcella L; Alushi B Source: American Journal of Medical Genetics. Part A. 2009 Jun 5; Abstract: Congenital malformations are relatively frequent (2% of the general population) but only a small proportion of them can be ascribed to medication exposure during pregnancy. Nevertheless, for the purposes of accurate prenatal diagnosis, monitoring and research, is it important to offer teratology counseling to patients exposed to drugs. There are approximately 20 medications currently on the market that have been universally acknowledged as teratogenic. At the current state of the art, exposure of early embryos to oral contraceptives is not considered teratogenic. Oral contraceptive use may be continuous (estrogen and progesterone or progesterone alone) or emergency (levonorgestrel is the only drug authorized in Italy). Like all drugs, oral contraceptives have a therapeutic failure rate, which means that a number of women on oral contraceptives conceive each year and request genetic counseling about teratogenic effects. During the period 1998-2006 at our genetics clinic we received 89 requests for counseling regarding teratogenic risk due to oral contraceptives. Our study of these patients confirms an absence of teratogenic risk for pregnancies occurring during oral contraceptive use. Teratology counseling was useful to reassure the mothers about the low risk (in the case of oral contraceptive use alone), since only 12 women chose to terminate pregnancy. Language: English Keywords: ITALY | RESEARCH REPORT | GENETICS | COUNSELING | EXPOSURE | ORAL CONTRACEPTIVES | CONTRACEPTIVE AGENTS, ESTROGEN | PROGESTERONE | LEVONORGESTREL | CONGENITAL ABNORMALITIES | RISK FACTORS | PREGNANCY | Developed Countries | Europe, Southern | Europe | Biology | Clinic Activities | Program Activities | Programs | Organization and Administration | Health | Contraceptive Methods | Contraception | Family Planning | Contraceptive Agents, Female | Contraceptive Agents | Progestational Hormones | Hormones | Endocrine System | Physiology | Contraceptive Agents, Progestin | Neonatal Diseases and Abnormalities | Diseases | Reproduction Document Number: 341602 |
| 8. Title: Limited knowledge on progestogen-only contraception and risk of venous thromboembolism. Author: Bergendal A; Odlind V; Persson I; Kieler H Source: Acta Obstetricia et Gynecologica Scandinavica. 2009;88(3):261-266. Abstract: Objective. To assess the current knowledge concerning progestogen-only contraception (POC) and risks of venous thromboembolism (VTE). Design and setting. Systematic review of the literature on observational and analytical studies reporting risk estimates for VTE in women exposed to POCs. Methods and main outcome measures. We performed a computerized literature search in the Pub Med, Embase, and the Cochrane Library for studies published between 1966 and February 13, 2008. Based on the evaluated studies we calculated an overall risk estimate for VTE in association with POC. Results. Four case-control studies and one cohort study were included. Of the case-control studies, three reported an increased risk and one a decreased risk of VTE. The cohort study found divergent results depending on the type of statistical analysis used. None of the results was statistically significant. The overall odds ratio for POC-associated VTE in the four case-control studies was 1.45 (95% CI=0.92-2.26). Conclusions. The risk of VTE associated with use of POCs is poorly investigated. The slightly elevated overall risk estimate might suggest an association between POC and an increased risk for VTE. The results must, however, be interpreted with caution due to the possibility of residual confounding. Well-designed studies with sufficient statistical power to evaluate risks of VTE with POC are warranted. Language: English Keywords: SWEDEN | RESEARCH REPORT | EPIDEMIOLOGY | CONTRACEPTIVE AGENTS, PROGESTIN | PROGESTERONE | THROMBOEMBOLISM | RISK FACTORS | KNOWLEDGE | Europe, Northern | Europe | Developed Countries | Public Health | Health | Contraceptive Agents, Female | Contraceptive Agents | Contraception | Family Planning | Progestational Hormones | Hormones | Endocrine System | Physiology | Biology | Embolism | Vascular Diseases | Diseases | Sociocultural Factors Document Number: 329655 |
| 9. Title: Novel progesterone receptor modulators with gene selective and context-dependent partial agonism. Author: Berrodin TJ; Jelinsky SA; Graciani N; Butera JA; Zhang Z; Nagpal S; Winneker RC; Yudt MR Source: Biochemical Pharmacology. 2009 Jan 15;77(2):204-15. Abstract: Progesterone receptor (PR) modulators are used in contraception and post-menopausal hormone therapy, and are under clinical development for reproductive disorders such as uterine fibroids and endometriosis. Development of tissue selective PR modulators (SPRMs) with reduced side effects and improved pharmacology represents a large unmet medical need in the area of women's health. One approach to addressing this need is to focus on the two PR isoforms PR-A and PR-B. In vitro and in vivo studies have revealed both distinct as well as overlapping gene regulation and functional responses of the two PR isoforms that suggests that PR-A selective modulators may retain a desired biological profile. We have identified a chemical series of 4-(4-chlorophenyl)-substituted piperazine carbimidothioic acid esters (PCEs) that have partial PR agonist activity and selectively activate some PR-A isoform regulated genes in T47D cells. However, full microarray analysis in these cells does not predict a global isoform selective profile for these compounds, but rather a unique gene-selective profile is observed relative to steroidal progestins. Using multiplexed peptide interaction profiling and co-activator recruitment assays we find that the mechanism of partial agonism is only partly defined by the ability to recruit known co-activators or peptides but also depends on the cell and promoter context of the gene under investigation. The data demonstrate global consequences of mechanistic and functional differences that can lead to selective biological responses of novel steroid receptor modulators. Language: English Keywords: UNITED STATES OF AMERICA | RESEARCH REPORT | UTERINE EFFECTS | ENDOMETRIOSIS | NEEDS | WOMEN'S HEALTH | PROGESTERONE | SCREENING | LABORATORY PROCEDURES | Developed Countries | North America | Americas | Uterus | Genitalia, Female | Genitalia | Urogenital System | Physiology | Biology | Diseases | Economic Factors | Health | Progestational Hormones | Hormones | Endocrine System | Examinations and Diagnoses | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Laboratory Examinations and Diagnoses Document Number: 329730 |
| 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. Peer Reviewed Title: A longitudinal comparison of body composition changes in adolescent girls receiving hormonal contraception. Author: Bonny AE; Secic M; Cromer BA Source: Journal of Adolescent Health. 2009 Oct;45(4):423-5. Abstract: The objective of this study was to examine body composition changes in adolescent girls initiating depot medroxyprogesterone acetate (DMPA), oral contraceptives, or no hormonal contraceptive method. At 6 months, DMPA resulted in significant increases in adiposity with concomitant decreases in lean body mass. Supplemental estrogen may lessen these DMPA effects. Language: English Keywords: UNITED STATES OF AMERICA | RESEARCH REPORT | COMPARATIVE STUDIES | LONGITUDINAL STUDIES | CONTROL GROUPS | ADOLESCENTS, FEMALE | DEPO-PROVERA | ORAL CONTRACEPTIVES | BODY WEIGHT | OBESITY | ESTROGENS | Developed Countries | North America | Americas | Studies | Research Methodology | Adolescents | Youth | Age Factors | Population Characteristics | Demographic Factors | Population | Medroxyprogesterone Acetate | Contraceptive Agents, Progestin | Contraceptive Agents, Female | Contraceptive Agents | Contraception | Family Planning | Contraceptive Methods | Physiology | Biology | Hormones | Endocrine System Document Number: 342847 |
| 12. Title: Emergency contraception, efficacy and public health impact. Author: Broekhuizen FF Source: Current Opinion In Obstetrics and Gynecology. 2009 May 30; Abstract: PURPOSE OF REVIEW: Emergency contraception in the past two decades had been proven to be effective and well tolerated. Counseling and advance provision and prescription of emergency contraception have been embraced by professional organizations in practice guidelines for its potential to reduce the number of unintended pregnancies and abortions. Has emergency contraception lived up to that promise? RECENT FINDINGS: Mifepristone (not available in the USA) is the agent of choice. Emergency contraception has not reduced the number of unintended pregnancies. Acceptance by healthcare providers and the public has not been optimal, and multiple financial and healthcare system barriers to use emergency contraception continue to exist. The public health impact of emergency contraception has been disappointing. SUMMARY: Although emergency contraception may continue to be an important component of contraceptive practice, only increased access to more effective methods of contraception will change unintended pregnancy rates. The use of mifepristone for emergency contraception in the USA must be considered. Language: English Keywords: UNITED STATES OF AMERICA | RESEARCH REPORT | EMERGENCY CONTRACEPTION | PREGNANCY, UNPLANNED | RU-486 | PUBLIC HEALTH | Developed Countries | North America | Americas | Contraception | Family Planning | Reproductive Behavior | Fertility | Population Dynamics | Demographic Factors | Population | Hormone Antagonists | Hormones | Endocrine System | Physiology | Biology | Health Document Number: 341569 |
| 13. Peer Reviewed Title: Insulin sensitivity and lipid metabolism with oral contraceptives containing chlormadinone acetate or desogestrel: a randomized trial. Author: Cagnacci A; Ferrari S; Tirelli A; Zanin R; Volpe A Source: Contraception. 2009 Feb;79(2):111-6. Abstract: BACKGROUND: Second-generation and third-generation oral contraceptives containing 30 mcg or more of ethinylestradiol (EE) decrease insulin sensitivity (SI). In this study, we investigated whether SI is decreased by contraceptives containing lower doses EE or by progestins with antiandrogenic properties. STUDY DESIGN: Twenty-eight young healthy women were randomly allocated to receive 20 mcg of EE and 150 mcg of desogestrel (DSG) (n=14) or 30 mcg of EE and 2 mg of chlormadinone acetate (CMA) (n=14) for 6 months. SI and glucose utilization independent of insulin (Sg) were investigated by the minimal model method. Lipid modifications were also analyzed. RESULTS: SI decreased with EE/DSG (7.09+/-1.4 vs. 4.30+/-0.91; p=.04; n=12), but not with EE/CMA (5.79+/-0.93 vs. 6.79+/-1.1; p=.48; n=12). SI modifications observed in the two groups were significantly different (-2.79+/-1.15 vs. 1.0+/-1.38; p=.05). Sg did not vary with either treatment. The response of C-peptide to glucose increased, but significantly so only with EE/CMA (p=.01). The C-peptide/insulin response increased with both EE/DSG (p=.05) and EE/CMA (p=.04). High-density lipoprotein (HDL) cholesterol (p=.02) and triglycerides (p=.02 and p=.01) increased in both groups, but HDL/low-density lipoprotein cholesterol (p=.02), apoprotein A1 (Apo-A1) (p=.04) and Apo-A1/apoprotein B (p=.048) increased significantly only with EE/CMA. CONCLUSIONS: The present study confirms that DSG, even when associated with low EE dose, decreases SI. By contrast, EE/CMA does not deteriorate SI and induces a favorable lipid profile. Language: English Keywords: ITALY | RESEARCH REPORT | CLINICAL TRIALS | WOMEN | PROGESTERONE | DESOGESTREL | CONTRACEPTION | ORAL CONTRACEPTIVES | LIPIDS | METABOLIC EFFECTS | SIDE EFFECTS | Developed Countries | Europe, Southern | Europe | Clinical Research | Research Methodology | Demographic Factors | Population | Progestational Hormones | Hormones | Endocrine System | Physiology | Biology | Contraceptive Agents, Progestin | Contraceptive Agents, Female | Contraceptive Agents | Family Planning | Contraceptive Methods | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health Document Number: 329611 |
| 14. 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 |
| 15. Peer Reviewed Title: A randomized trial to compare two dosing intervals of misoprostol following mifepristone administration in second trimester medical abortion. Author: Chai J; Tang OS; Hong QQ; Chen QF; Cheng LN; Ng E; Ho PC Source: Human Reproduction. 2009 Feb;24(2):320-4. Abstract: BACKGROUND: The conventional timing of misoprostol administration after mifepristone for second trimester medical abortion is 36-48 h, but simultaneous administration, which may make the regimen more convenient, has not been studied. The objective of this randomized comparison study is to compare two intervals of administration of misoprostol after pretreatment with mifepristone for second trimester medical abortion. METHODS: Eligible women with gestational age between 12 and 20 weeks were randomized to receive mifepristone 200 mg orally followed by 600 microg misoprostol vaginally either immediately or 36-38 h later, followed by 400 microg vaginal misoprostol every 3 h for a maximum of four doses. The primary outcome measure was the success rate at 24 h after the start of misoprostol treatment and the secondary outcome measures were the induction-to-abortion interval and the frequency of side effects. RESULTS: There was a significant difference in the success rate at 24 h (36-38 h: 100%; immediate: 91.5%). The median induction-to-abortion interval was significantly shorter in the 36-38 h regimen (4.9 h) compared with the immediate regimen (10 h). Side effects in terms of febrile episodes and chills/rigors were significantly higher in the immediate administration group. CONCLUSIONS: Simultaneous use of mifepristone and misoprostol for second trimester medical abortion is not as effective as the regimen using a 36-38 h dosing interval. Language: English Keywords: CHINA | HONG KONG | RESEARCH REPORT | CLINICAL RESEARCH | PREGNANT WOMEN | WOMEN IN DEVELOPMENT | ABORTION | ADMINISTRATION AND DOSAGE | MISOPROSTOL | RU-486 | PREGNANCY, SECOND TRIMESTER | TIME FACTORS | SIDE EFFECTS | Asia, Eastern | Asia | Developing Countries | Developed Countries | Research Methodology | Population Characteristics | Demographic Factors | Population | Economic Development | Economic Factors | Fertility Control, Postconception | Family Planning | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Prostaglandins, Synthetic | Prostaglandins | Endocrine System | Physiology | Biology | Hormone Antagonists | Hormones | Pregnancy | Reproduction | Population Dynamics Document Number: 331075 Notification |
| 16. Title: Mifepristone plus vaginal misoprostol vs vaginal misoprostol alone for medical abortion in gestation 63 days or less in Nepalese women: a quasi-randomized controlled trial. Author: Chawdhary R; Rana A; Pradhan N Source: Journal of Obstetrics and Gynaecology Research. 2009 Feb;35(1):78-85. Abstract: AIM: To compare the efficacy of mifepristone and vaginal misoprostol with misoprostol alone for pregnancy termination up to 63 days. METHOD: This exploratory study was conducted in the Department of Obstetrics and Gynecology, Tribhuvan University Teaching Hospital, Kathmandu, Nepal as a part of a thesis study for a period of one year from April 2005-2006. After confirming a pregnancy < or =63 days gestation by transvaginal ultrasound, an equal number of women (50) were randomized into (i) group A, women who received 200 mg oral mifepristone (RU 486) on day 1 and vaginal misoprostol 800 microg on day 3; and (ii) group B, women who received vaginal misoprostol (800 microg) on day 1 and 3 (total dose 1600 microg). The primary study outcome measure was complete abortion without surgical intervention making comparisons between these two groups in terms of complete abortion rate, need for manual vacuum aspiration for incomplete abortion and pregnancy continuation after reconfirming the diagnosis on transvaginal ultrasound, besides comparing the side effects/complications. RESULTS: Fewer side effects and a more complete abortion rate (94%) was observed in group A (mifepristone and vaginal misoprostol) in comparison to vaginal misoprostol alone (total dose 1600 microg) giving a complete abortion rate of 86% along with a significant hematocrit drop on follow-up day 10 (P = 0.03) besides having increased duration of bleeding (P = 0.017). CONCLUSION: Mifepristone oral (200 mg) followed by vaginal misoprostol (800 microg) on day 3 provides a better success rate (94%) with fewer complications than vaginal misoprostol 800 microg used on days 1 and 3 for medical abortion of pregnancies up to 63 days. Language: English Keywords: NEPAL | RESEARCH REPORT | CLINICAL TRIALS | COMPARATIVE STUDIES | WOMEN IN DEVELOPMENT | PREGNANT WOMEN | RU-486 | MISOPROSTOL | ABORTION | VAGINA | ULTRASONICS | ADMINISTRATION AND DOSAGE | TIME FACTORS | CONTRACEPTIVE AGENTS, SIDE EFFECTS | PREGNANCY, FIRST TRIMESTER | Developing Countries | Asia, Southern | Asia | Clinical Research | Research Methodology | Studies | Economic Development | Economic Factors | Population Characteristics | Demographic Factors | Population | Hormone Antagonists | Hormones | Endocrine System | Physiology | Biology | Prostaglandins, Synthetic | Prostaglandins | Fertility Control, Postconception | Family Planning | Genitalia, Female | Genitalia | Urogenital System | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Drugs | Treatment | Population Dynamics | Contraceptive Agents | Contraception | Pregnancy | Reproduction Document Number: 341125 |
| 17. Title: Blockade of alpha(1A)-adrenoceptor: A novel possible strategy for male contraception. Author: Chen Y; Li H; Dong Q; Wang KJ Source: Medical Hypotheses. 2009;73:140-141. Abstract: Worldwide almost one quarter of all couples practicing contraception rely on male methods. However, currently available options for male contraception are limited. Thus, it is urgent to develop safe, effective, and reversible male contraceptives. To date, alpha(1)-blockers are the most widely used agents for the treatment of benign prostatic hyperplasia. Several studies reveal that in elderly patients the alpha(1A)-selective antagonist tamsulosin can induce a notably high incidence of ejaculation dysfunction characterized by low ejaculate volume. Recent clinical trials suggest that tamsulosin may effectively inhibit sperm ejaculation in young volunteers. Since alpha(1A)-adrenoceptor subtype plays a dominant role in mediating the contractions of accessory sex organs contributing to ejaculation, we hypothesize that blockade of alpha(1A)-adrenoceptor may suppress the motility of these organs, thereby inhibiting sperm transport and achieving contraception, and the alpha(1A)-selective antagonists can act as a male contraceptive. If our hypotheses can be further supported with clinical trials it will shift the paradigm for male-based contraception and provide a wider range of choice for all. Language: English Keywords: CHINA | RESEARCH PROPOSAL | LITERATURE REVIEW | CLINICAL RESEARCH | MEN | MALE CONTRACEPTION | HORMONE ANTAGONISTS | SPERM TRANSPORT INHIBITION | Asia, Eastern | Asia | Developing Countries | Research Methodology | Demographic Factors | Population | Contraception | Family Planning | Hormones | Endocrine System | Physiology | Biology | Inhibition of Fertilization | Contraceptive Mode of Action Document Number: 341144 |
| 18. Peer Reviewed Title: Effect of previous live birth and prior route of delivery on the outcome of early medical abortion. Author: Chien LW; Liu WM; Tzeng CR; Au HK Source: Obstetrics and Gynecology. 2009 Mar;113(3):669-74. Abstract: OBJECTIVE: To determine the association between type of previous delivery (vaginal compared with cesarean) on the success of medical abortion with mifepristone-misoprostol in early pregnancy. METHODS: The records of 879 women with intrauterine pregnancies at or before 56 days of gestation who underwent medical abortions were reviewed. Medical treatment consisted of 600 mg mifepristone orally followed 48 hours later with oral misoprostol. An ultrasound examination was performed 14-21 days after treatment, and a successful medical abortion was defined as an empty uterus without surgical intervention. Univariable and multivariable logistic regressions were used to determine risk factors for failure of medical abortion. RESULTS: A total of 797 (90.7%) women had successful medical abortions; 82 (9.3%) had failed medical abortions. Multivariable logistic regression indicated that women with gestational ages greater than 42 days (odds ratio [OR] 2.53, 95% confidence interval [CI] 1.55-4.05) had higher odds of failed abortion compared with a gestational age less than 43 days. Parous women (OR> or =3.94, 95% CI 1.83-8.53) and those with prior cesarean delivery (OR 9.59, 95% CI 4.30-21.39) were more likely to have failed abortions compared with nulliparous women. Among 523 parous women (68 had failed abortion), those with gestational ages greater than 42 days (OR 2.07, 95% CI 1.22-3.50) and prior cesarean delivery (OR 3.33, 95% CI 1.95-5.69) were more likely to have failed abortions compared with those with gestational ages less than 43 days or with prior vaginal delivery. CONCLUSION: Parous women are at increased risk for failed medical abortion in comparison with nulliparous women. Prior cesarean delivery is significantly associated with failed medical abortion. Language: English Keywords: TAIWAN | RESEARCH REPORT | EPIDEMIOLOGIC METHODS | CLINICAL RESEARCH | COMPARATIVE STUDIES | PREGNANT WOMEN | WOMEN IN DEVELOPMENT | PREVALENCE | CHILDBIRTH | ABORTION | CESAREAN SECTION | RU-486 | PREGNANCY, FIRST TRIMESTER | MISOPROSTOL | Asia, Eastern | Asia | Developed Countries | Research Methodology | Studies | Population Characteristics | Demographic Factors | Population | Economic Development | Economic Factors | Measurement | Pregnancy Outcomes | Pregnancy | Reproduction | Fertility Control, Postconception | Family Planning | Obstetrical Surgery | Surgery | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Hormone Antagonists | Hormones | Endocrine System | Physiology | Biology | Prostaglandins, Synthetic | Prostaglandins Document Number: 331067 Notification |
| 19. Peer Reviewed Title: Progestogen-only contraceptive use in obese women. Author: Curtis KM; Ravi A; Gaffield ML Source: Contraception. 2009 Oct;80(4):346-54. Abstract: BACKGROUND: The objective of this systematic review is to determine whether obese women who use progestogen-only contraceptives are more likely to experience weight gain or serious adverse events as compared to nonobese users. STUDY DESIGN: We searched PubMed for all articles (in all languages) published in peer-reviewed journals from database inception through October 2008, for evidence relevant to obesity and progestogen-only contraceptives. We used standard abstract forms and grading systems to summarize and assess the quality of the evidence. RESULTS: From 579 articles, we identified nine studies fitting our selection criteria. Evidence from five studies suggests that among adult women, baseline weight or body mass index is not associated with weight gain among depot medroxyprogesterone acetate (DMPA) users (Level II-2, Fair). Evidence from three studies suggests that among adolescent women, overweight or obese DMPA users may gain more weight than normal weight DMPA users or overweight/obese nonusers (Level II-2, Fair). Evidence from one small study of Norplant users showed no differences in weight gain by baseline weight (Level II-3, Poor). We did not identify studies of other progestogen-only contraceptive methods that examined weight change by baseline weight, nor did we identify studies that reported on any serious adverse events by baseline weight. CONCLUSIONS: Adolescent DMPA users who are obese may gain more weight than normal weight users. This observation was not seen in adult DMPA users or adolescent Norplant users. Language: English Keywords: GLOBAL | LITERATURE REVIEW | ADULTS | ADOLESCENTS, FEMALE | CONTRACEPTIVE AGENTS, PROGESTIN | PROGESTERONE | DEPO-PROVERA | CONTRACEPTIVE IMPLANTS | CONTRACEPTIVE AGENTS, SIDE EFFECTS | OBESITY | BODY WEIGHT | Age Factors | Population Characteristics | Demographic Factors | Population | Adolescents | Youth | Contraceptive Agents, Female | Contraceptive Agents | Contraception | Family Planning | Progestational Hormones | Hormones | Endocrine System | Physiology | Biology | Medroxyprogesterone Acetate | Contraceptive Methods Document Number: 342772 |
| 20. 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 |
| 21. 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 |
| 22. Peer Reviewed Title: Profile of the progesterone derivative chlormadinone acetate - pharmocodynamic properties and therapeutic applications. Author: Druckmann R Source: Contraception. 2009 Apr;79(4):272-81. Abstract: Chlormadinone acetate (CMA) is a derivative of progesterone (17alpha-acetoxy-6-chloro-4,6-pregnadiene-3,20-dione), first synthesized in 1961 and is used as an orally effective progestogen in hormone replacement therapy (HRT), and in combination with ethinyl estradiol (EE) in contraception since 1999. Chlormadinone acetate has a strong progestogenic effect - about one-third higher than that of progesterone - and may vary depending on the previous effect of an estrogen, i.e., estrogens may promote the formation of progesterone receptors and proliferation of the endometrium. Like progesterone, it is anti-estrogenic and has no partial androgenic effect (at the doses used for contraception and HRT). In contrast to progesterone, it has a slight glucocorticoid effect, a pronounced anti-androgenic effect and no anti-mineralocorticoid effect. No pregnancy-maintaining effect of CMA has been demonstrated in humans. The anti-androgenic effect of CMA is presumed to be the result of both its binding to androgen receptors - competitively inhibiting the effect of endogenous testosterone and dihydrotestosterone - and the competitive inhibition of 5alpha-reductase. In this respect, dosing of CMA is crucial; agonistic effects are observed when doses are increased from those optimal for an antagonistic effect. Chlormadinone acetate has a strong anti-gonadotropic effect, through negative feedback on gonadotropin secretion, and has been used for more than 20 years alone for contraception in arterial risk patients. The clinical and metabolic tolerability of CMA has been demonstrated in numerous clinical studies with duration of treatment of up to 2.5 years. The more recent application of CMA as an oral contraceptive in combination with EE (Neo Eunomin, Belara) has proven highly successful, with studies reporting excellent contraceptive efficacy, high tolerability and adherence due to a good side effect profile and positive effects on preexisting dysmenorrhea, skin and hair conditions. Language: English Keywords: FRANCE | RESEARCH REPORT | ORAL CONTRACEPTIVES | CONTRACEPTIVE AGENTS, PROGESTIN | PROGESTERONE | CONTRACEPTIVE EFFECTIVENESS | Developed Countries | Europe, Western | Europe | Contraceptive Methods | Contraception | Family Planning | Contraceptive Agents, Female | Contraceptive Agents | Progestational Hormones | Hormones | Endocrine System | Physiology | Biology Document Number: 341633 |
| 23. 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 |
| 24. Title: Oral Contraceptives Decrease Saliva Testosterone but Do Not Affect the Rise in Testosterone Associated with Athletic Competition. Author: Edwards DA; Laurel O'Neal J Source: Hormones and Behavior. 2009 Jan 30; Abstract: Women athletes from intercollegiate soccer, volleyball, and softball teams, and women skaters from a team competing in an amateur roller derby league, contributed saliva samples before warm-up and immediately after the completion of one or more sanctioned competitions. Women using oral contraceptives (OCs, n= 29) had a significantly lower mean level of saliva testosterone (T) than non-users (n= 51). Thus, OCs contribute predictable variation to individual differences in saliva T, and OC use is likely to contribute to individual differences in measures of psychological processes and/or behavior which are causally related to individual differences in circulating testosterone. Most of the women (n= 68) played during one or more of the competitions for which they contributed saliva samples. Whether for soccer, volleyball, softball, or roller derby, competition was associated with a robust increase in saliva T. Although OC users had significantly lower saliva T levels than non-users before and after-competition, both users and non-users showed virtually the same increase in saliva T over the course of competition. While the most proximal cause of this increase is not known, it is probably not the result of an increase in gonadotropin (GTH) secretion since an increase in GTH secretion would presumably be prevented by OC use. Language: English Keywords: UNITED STATES OF AMERICA | RESEARCH REPORT | WOMEN | ATHLETES | SPORTS | GONADOTROPINS, PITUITARY | ORAL CONTRACEPTIVES | Developed Countries | North America | Americas | Demographic Factors | Population | Population Characteristics | Social Behavior | Behavior | Gonadotropins | Hormones | Endocrine System | Physiology | Biology | Contraceptive Methods | Contraception | Family Planning Document Number: 341370 |
| 25. 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 |
| 26. Title: Effects of menstrual cycle, oral contraception, and training on exercise-induced changes in circulating DHEA-sulphate and testosterone in young women. Author: Enea C; Boisseau N; Ottavy M; Mulliez J; Millet C; Ingrand I; Diaz V; Dugue B Source: European Journal of Applied Physiology. 2009;106:365-373. Abstract: The objective of this study was to ascertain the effects of menstrual cycle, oral contraception, and training status on the exercise-induced changes in circulating DHEA-sulphate and testosterone in young women. Twenty-eight healthy women were assigned to an untrained group (n = 16) or a trained group (n = 12) depending on their training background. The untrained group was composed of nine oral contraceptive users (OC+) and seven eumenorrheic women (OC-). The trained group was composed of OC+ subjects only. All the OC+ subjects were taking the same low-dose oral contraception. Three laboratory sessions were organised in a randomised order: a prolonged exercise test until exhaustion, a short-term exhaustive exercise test, and a control session. Blood specimens were collected before, during and after the exercise tests and at the same time of the day during the control session. Basal circulating testosterone was significantly lower in trained as compared to untrained subjects. In all subjects, the prolonged exhaustive exercise induced a significant increase in circulating DHEA-s and testosterone. The short-term exercise induced a significant increase in circulating DHEA-s in untrained eumenorrheic and in trained OC users only. Menstrual phases in OC- did not influence the responses. It was found that exhaustive physical exercise induced an increase in circulating DHEA-s and testosterone in young women. Oral contraception may limit short-term exercise-induced changes. Language: English Keywords: FRANCE | RESEARCH REPORT | WOMEN | PHYSIOLOGY | ANDROGENS | FITNESS | METABOLIC EFFECTS | Developed Countries | Europe, Western | Europe | Demographic Factors | Population | Biology | Hormones | Endocrine System | Health Document Number: 330573 |
27.  Title: Termination of missed abortion in a combined procedure: a randomized controlled trial. Author: Fang AF; Chen QF; Zheng W; Li YH; Chen RY Source: Journal of Reproduction and Contraception. 2009 Mar;20(1):45-49. Abstract: Objective To access an ideal procedure terminating missed abortion within 12 weeks of gestational age. Methods Women with intrauterine fetal death were randomized into 3 groups. Group A (n=30): vaginal misoprostol (MP) 0.4 mg, 3 h before vacuum aspiration; group B(n=15): vaginal MP 0.4 mg every 3 h, up to 5 doses; group C(n=30): oral mifepristone (MF) 200 mg 36-48 h before vaginal MP 0.4 mg, MP was given every 3 h, up to 5 doses. Results Women in group A had the shortest interval of gestation tissue expulsion (3.2 - 0.5 h) and the bleeding (3.2 + 5.7 ml) during medical procedure, which were statistically significant in comparison with the other two groups (P<0.001, P<0.01, respectively). Success rates of groups A, B and C were 100%, 33.3% and 90.0%, respectively. Percentages of women need surgical interventions were similar in group B and group C(80.0%,76.7%, respectively). Bleeding during operation, pain after medical procedure and satisfaction presented no statistical significance among the 3 groups. Conclusion Vaginal MP followed by vacuum aspiration was valuable in safety, and efficacy, which led to less bleeding and a faster recovery. Language: English Keywords: CHINA | RESEARCH REPORT | CLIENTS | CLINICAL TRIALS | FETAL DEATH | ABORTION | MISOPROSTOL | RU-486 | ADMINISTRATION AND DOSAGE | Asia, Eastern | Asia | Developing Countries | Program Activities | Programs | Organization and Administration | Clinical Research | Research Methodology | Mortality | Population Dynamics | Demographic Factors | Population | Fertility Control, Postconception | Family Planning | Prostaglandins, Synthetic | Prostaglandins | Endocrine System | Physiology | Biology | Hormone Antagonists | Hormones | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health Document Number: 341510 |
| 28. Peer Reviewed Title: Rates of serious infection after changes in regimens for medical abortion. Author: Fjerstad M; Trussell J; Sivin I; Lichtenberg ES; Cullins V Source: New England Journal of Medicine. 2009 Jul 9;361(2):145-51. Abstract: BACKGROUND: From 2001 through March 2006, Planned Parenthood health centers throughout the United States provided medical abortion (abortion by means of medication) principally by a regimen of oral mifepristone followed 24 to 48 hours later by vaginal misoprostol. In response to concern about serious infections, in early 2006 Planned Parenthood changed the route of misoprostol administration from vaginal to buccal and required either routine provision of antibiotics or universal screening and treatment for chlamydia; in July 2007, Planned Parenthood began requiring routine treatment with antibiotics for all medical abortions. METHODS: We performed a retrospective analysis assessing the rates of serious infection after medical abortion during a time when misoprostol was administered vaginally (through March 2006), as compared with rates after a change to buccal administration of misoprostol and after initiation of additional infection-reduction measures. RESULTS: Rates of serious infection dropped significantly after the joint change to buccal misoprostol from vaginal misoprostol and to either testing for sexually transmitted infection or routine provision of antibiotics as part of the medical abortion regimen. The rate declined 73%, from 0.93 per 1000 abortions to 0.25 per 1000 (absolute reduction, 0.67 per 1000; 95% confidence interval [CI], 0.44 to 0.94; P<0.001). The subsequent change to routine provision of antibiotics led to a further significant reduction in the rate of serious infection - a 76% decline, from 0.25 per 1000 abortions to 0.06 per 1000 (absolute reduction, 0.19 per 1000; 95% CI, 0.02 to 0.34; P=0.03). CONCLUSIONS: The rate of serious infection after medical abortion declined by 93% after a change from vaginal to buccal administration of misoprostol combined with routine administration of antibiotics. Language: English Keywords: UNITED STATES OF AMERICA | RESEARCH REPORT | RETROSPECTIVE STUDIES | STATISTICAL STUDIES | ABORTION | RU-486 | MISOPROSTOL | ADMINISTRATION AND DOSAGE | STANDARDS | INFECTION PREVENTION | ANTIBIOTICS | MONITORING | Developed Countries | North America | Americas | Studies | Research Methodology | Fertility Control, Postconception | Family Planning | Hormone Antagonists | Hormones | Endocrine System | Physiology | Biology | Prostaglandins, Synthetic | Prostaglandins | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Infections | Diseases | Evaluation Document Number: 342147 Notification |
| 29. 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 |
| 30. Title: Choosing medical or surgical terminations of pregnancy in the first trimester: what is the difference? Author: Goodyear-Smith F; Knowles A Source: Australian and New Zealand Journal of Obstetrics and Gynaecology. 2009 Apr;49(2):211-5. Abstract: BACKGROUND: Women seeking termination of pregnancy in Auckland, New Zealand can chose between medical and surgical options up to eight weeks gestation. AIMS: To assess demographic differences or changes over time between proportions of women choosing medical or surgical abortions at a single centre and determine whether changing the mifepristone-misoprostol interval from two to one day impacted on outcomes. METHODS: Retrospective audit of two consecutive years (December 2005-November 2006 and December 2006-November 2007) of first-trimester surgical and medical terminations where the mifepristone-misoprostol interval was reduced from two to one day between years. Analysis using descriptive statistics and assessment of probability of observed differences between groups. RESULTS: A total of 1495 terminations were performed in 2005-2006 and 1588 in 2006-2007. No significant difference (P = 0.4) of eligible women choosing medical (21% and 23%) or surgical abortion between years. Ethnicity, age and residency status did not influence choice. Medical termination of pregnancy was more likely in women who were without previous children (P = 0.009), pregnancies (P = 0.02) or terminations (P = 0.04). Medical termination was similarly effective within six hours with either two- or one-day intervals. CONCLUSIONS: Both medical and surgical first-trimester abortions are safe and effective. It is optimal to be able to offer women choice. Reducing the medical interval to one day does not increase adverse outcomes. Language: English Keywords: NEW ZEALAND | RESEARCH REPORT | RETROSPECTIVE STUDIES | ABORTION | PREGNANCY, FIRST TRIMESTER | MISOPROSTOL | RU-486 | ADMINISTRATION AND DOSAGE | ANALGESIA | Oceania | Developed Countries | Studies | Research Methodology | Fertility Control, Postconception | Family Planning | Pregnancy | Reproduction | Prostaglandins, Synthetic | Prostaglandins | Endocrine System | Physiology | Biology | Hormone Antagonists | Hormones | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health Document Number: 342383 Notification |
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