Explore the vast range of titles available.

Emergency contraception can prevent unintended pregnancies, but current methods are only effective if used as soon as possible after sexual intercourse and before ovulation. We compared the efficacy and safety of ulipristal acetate with levonorgestrel for emergency contraception. Women with regular menstrual cycles who presented to a participating family planning clinic requesting emergency contraception within 5 days of unprotected sexual intercourse were eligible for enrolment in this randomised, multicentre, non-inferiority trial. 2221 women were randomly assigned to receive a single, supervised dose of 30 mg ulipristal acetate (n=1104) or 1·5 mg levonorgestrel (n=1117) orally. Allocation was by block randomisation stratified by centre and time from unprotected sexual intercourse to treatment, with allocation concealment by identical opaque boxes labelled with a unique treatment number. Participants were masked to treatment assignment whereas investigators were not. Follow-up was done 5–7 days after expected onset of next menses. The primary endpoint was pregnancy rate in women who received emergency contraception within 72 h of unprotected sexual intercourse, with a non-inferiority margin of 1% point difference between groups (limit of 1·6 for odds ratio). Analysis was done on the efficacy-evaluable population, which excluded women lost to follow-up, those aged over 35 years, women with unknown follow-up pregnancy status, and those who had re-enrolled in the study. Additionally, we undertook a meta-analysis of our trial and an earlier study to assess the efficacy of ulipristal acetate compared with levonorgestrel. This trial is registered with ClinicalTrials.gov, number NCT00551616. In the efficacy-evaluable population, 1696 women received emergency contraception within 72 h of sexual intercourse (ulipristal acetate, n=844; levonorgestrel, n=852). There were 15 pregnancies in the ulipristal acetate group (1·8%, 95% CI 1·0–3·0) and 22 in the levonorgestrel group (2·6%, 1·7–3·9; odds ratio [OR] 0·68, 95% CI 0·35–1·31). In 203 women who received emergency contraception between 72 h and 120 h after sexual intercourse, there were three pregnancies, all of which were in the levonorgestrel group. The most frequent adverse event was headache (ulipristal acetate, 213 events [19·3%] in 1104 women; levonorgestrel, 211 events [18·9%] in 1117 women). Two serious adverse events were judged possibly related to use of emergency contraception; a case of dizziness in the ulipristal acetate group and a molar pregnancy in the levonorgestrel group. In the meta-analysis (0–72 h), there were 22 (1·4%) pregnancies in 1617 women in the ulipristal acetate group and 35 (2·2%) in 1625 women in the levonorgestrel group (OR 0·58, 0·33–0·99; p=0·046). Ulipristal acetate provides women and health-care providers with an effective alternative for emergency contraception that can be used up to 5 days after unprotected sexual intercourse. HRA Pharma.

\"Globally, more than one fourth of all pregnancies are unintended. Emergency contraception can be used after sex to reduce the risk of pregnancy. But despite their safety and efficacy, emergency contraceptive pills (ECPs) have sparked controversy worldwide. In examining the journey of ECPs in fourteen countries, this volume explores the ways that a global reproductive health technology both acquires local cultural meaning and encounters similar challenges everywhere it is introduced worldwide. This book's portraits of activism and opposition highlight the range of social, cultural, religious, and political contexts that shape the interpretation of new medical technologies\"-- Provided by publisher.

A drug–drug interaction (DDI) study was conducted to evaluate the effect of icenticaftor (QBW251) on the pharmacokinetics (PK) of a 5‐probe cytochrome P450 (CYP) substrate cocktail, guided by in vitro studies in human hepatocytes and liver microsomes. Another DDI study investigated the effect of icenticaftor on the PK and pharmacodynamics (PD) of a monophasic oral contraceptive (OC) containing ethinyl estradiol (EE) and levonorgestrel (LVG) in premenopausal healthy female subjects. The static‐mechanistic DDI assessment indicated that icenticaftor may moderately induce the metabolic clearance of co‐medications metabolized by CYP3A4 (area under the concentration–time curve [AUC] ratio: 0.47) and potentially CYP2C; icenticaftor may also weakly inhibit the metabolic clearance of co‐medications metabolized by CYP1A2 and CYP3A4 (AUC ratio: 1.35 and 1.86, respectively) and moderately inhibit CYP2B6 (AUC ratio: 2.11). In the CYP substrate cocktail DDI study, icenticaftor 300 mg twice daily (b.i.d.) moderately inhibited CYP1A2 (AUC ratio: 3.35) and CYP2C19 (AUC ratio: 2.70). As expected from the results of the in vitro studies, weak induction was observed for CYP3A4 (AUC ratio: 0.51) and CYP2C8 (AUC ratio: 0.66). In the OC DDI study, co‐administration of icenticaftor 450 mg b.i.d. with monophasic OC containing 30‐μg EE and 150‐μg LVG once daily reduced the plasma exposure of both components by approximately 50% and led to increased levels of follicle‐stimulating hormone and luteinizing hormone. These results provide valuable guidance for the use of icenticaftor in patients taking concomitant medications that are substrates of CYP enzymes or patients using OCs.

Abstract Context Dimethandrolone (DMA) has androgenic and progestational activity. Single oral doses of DMA undecanoate (DMAU) were well tolerated and reversibly suppressed serum LH and testosterone (T) in men. Objective Assess safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of oral DMAU. Design Double-blind, randomized, placebo-controlled study. Setting Two academic medical centers. Participants Healthy men (18 to 50 years). Interventions One hundred men received DMAU [0, 100, 200, or 400 mg, formulated in castor oil/benzyl benzoate (C) or powder (P)] for 28 days. Subjects underwent 24-hour PK sampling on days 1 and 28 and twice weekly ambulatory visits throughout treatment. Main Outcome Measures Primary outcomes were safety and tolerability parameters (vitals, laboratory data, mood, and sexual function scores) and adverse events. Secondary outcomes were drug PK profiles and PD effects (serum LH, FSH, and sex hormones). Results Eighty-two subjects completed the study and were included in the analysis. There were no serious adverse events. No clinically significant changes developed in safety laboratory parameters. A significant dose effect was seen for weight, hematocrit, high-density lipoprotein cholesterol, corrected QT interval, and sexual desire. Serum 24-hour average concentrations of DMAU and DMA showed dose-related increases (P < 0.001). All six subjects in the P400 group and 12 of 13 subjects in the C400 group achieved marked suppression of LH and FSH (<1.0 IU/L) and serum T (<50 ng/dL). Conclusions Daily oral administration of DMAU for 28 days in healthy men is well tolerated. Doses of ≥200 mg markedly suppress serum T, LH, and FSH. These results support further testing of DMAU as a male contraceptive. Healthy men were administered oral DMAU daily for 28 days. DMAU was safe and markedly suppressed LH, FSH, and testosterone. DMAU holds promise as a male contraceptive.

Background/Objective: The oral contraceptive pill (OCP) is widely used by women worldwide, yet the influence of the OCP on carbohydrate metabolism remains under-investigated, with existing studies being few and largely cross-sectional. The study objective was to assess, for the first time, the effect of the combined OCP on postprandial glycaemic response to an oral glucose bolus, using a randomised crossover design. Methods: The effect of a combined monophasic OCP phase on glucose homeostasis and metabolic profile was investigated in 21 healthy young women, who were regular users of either androgenic or anti-androgenic OCP formulations. Plasma glycaemic markers (glucose, insulin and C-peptide) were assessed prior to a 60 g glucose drink (fasting) and for a further 4 h postprandially; once during the “active” (hormone-containing) pill phase and once during the “inactive” (hormone-free) pill phase of the OCP usage cycle. Results: Despite no change in fasting values, in androgenic pill users, postprandial glucose and insulin responses to an oral glucose bolus were ~100% and ~50% greater, respectively, during the active versus inactive phase. In contrast, in anti-androgenic pill users there was no significant change in response between the two OCP usage cycle phases. Conclusions: These findings highlight an acute, but potentially detrimental, influence of the combined OCP on glucose homeostasis, particularly in users of formulations containing androgenic progestogens. Given the high global prevalence of OCP use and increasingly common prolonged active pill regimens, which may continue for months, years or even decades, potential cumulative effects of such changes on metabolic risk demand further investigation.

As Louise Brown—the first baby conceived by in vitro fertilization—celebrates her 30th birthday, Margaret Marsh and Wanda Ronner tell the fascinating story of the man who first showed that human in vitro fertilization was possible. John Rock spent his career studying human reproduction. The first researcher to fertilize a human egg in vitro in the 1940s, he became the nation's leading figure in the treatment of infertility, his clinic serving rich and poor alike. In the 1950s he joined forces with Gregory Pincus to develop oral contraceptives and in the 1960s enjoyed international celebrity for his promotion of the pill and his campaign to persuade the Catholic Church to accept it. Rock became a more controversial figure by the 1970s, as conservative Christians argued that his embryo studies were immoral and feminist activists contended that he had taken advantage of the clinic patients who had participated in these studies as research subjects. Marsh and Ronner's nuanced account sheds light on the man behind the brilliant career. They tell the story of a directionless young man, a saloon keeper's son, who began his working life as a timekeeper on a Guatemalan banana plantation and later became one of the most recognized figures of the twentieth century. They portray his medical practice from the perspective of his patients, who ranged from the wives of laborers to Hollywood film stars. The first scholars to have access to Rock's personal papers, Marsh and Ronner offer a compelling look at a man whose work defined the reproductive revolution, with its dual developments in contraception and technologically assisted conception.

Since 2006, when the \"morning-after pill\" Plan B was first sold over the counter, sales of emergency contraceptives have soared, becoming an $80-million industry in the United States and throughout the Western world. But emergency contraception is nothing new. It has a long and often contentious history as the subject of clashes not only between medical researchers and religious groups, but also between different factions of feminist health advocates. The Morning Aftertells the story of emergency contraception in America from the 1960s to the present day and, more importantly, it tells the story of the women who have used it. Side-stepping simplistic readings of these women as either radical feminist trailblazers or guinea pigs for the pharmaceutical industry, medical historian Heather Munro Prescott offers a portrait of how ordinary women participated in the development and popularization of emergency contraception, bringing a groundbreaking technology into the mainstream with the potential to alter radically reproductive health practices.