Reproductive sciences
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Reproductive sciences · Dec 2014
Multicenter Study Comparative StudyEffect of a low-dose contraceptive patch on efficacy, bleeding pattern, and safety: a 1-year, multicenter, open-label, uncontrolled study.
This Phase III, uncontrolled, open-label, multicenter study was conducted to investigate the contraceptive efficacy, bleeding pattern, and cycle control of a novel once-a-week contraceptive patch, delivering low-dose ethinyl estradiol (EE) and gestodene (GSD) at the same systemic exposure seen after oral administration of a combined oral contraceptive containing 0.02 mg EE/0.06 mg GSD. Participants were women aged 18 to 35 years, all of whom received the EE/GSD patch for 13 cycles each of 21 treatment days (one patch per week for 3 weeks) followed by a 7-day, patch-free interval. The primary efficacy variable was the occurrence of unintended pregnancies during the study period as assessed by life table analysis and the Pearl Index. ⋯ Results suggest the EE/GSD patch is highly effective in preventing pregnancy. Menstrual bleeding pattern was favorable and within the ranges expected of a healthy female population. The patch was well tolerated and treatment compliance was high.
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Reproductive sciences · Mar 2014
Randomized Controlled Trial Multicenter StudyElagolix treatment for endometriosis-associated pain: results from a phase 2, randomized, double-blind, placebo-controlled study.
This Phase 2 study evaluated the safety and efficacy of elagolix for treating endometriosis-associated pain. A total of 155 women with laparoscopically confirmed endometriosis were randomized to placebo, elagolix 150 mg, or elagolix 250 mg once daily for 12 weeks. Placebo patients were rerandomized to elagolix and elagolix patients continued their dosing assignment for 12 additional weeks; the primary efficacy measure was changed from baseline in the monthly mean numerical rating scale for pain at week 12. ⋯ Monthly mean dysmenorrhea and nonmenstrual pelvic pain scores were reduced with elagolix, with significant differences for dysmenorrhea at weeks 8 and 12 versus placebo (P < .05). Minimal bone mineral density changes were observed with elagolix treatment. In women with endometriosis-associated pain, elagolix demonstrated an acceptable efficacy and safety profile in this Phase 2 study.
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Reproductive sciences · Dec 2007
Multicenter StudyRelation of daily urinary hormone patterns to vasomotor symptoms in a racially/ethnically diverse sample of midlife women: study of women's health across the nation.
The associations of urinary pregnanediol-glucuronide (PdG) levels and menstrual bleeding and their modification of associations of other risk factors with vasomotor symptoms (VMS) are examined. Daily urine samples were collected for 1 menstrual cycle or 50 days if no bleeding occurred. Participants (n = 742) were aged 43 to 54 years, not using exogenous hormones, not pregnant, had an intact uterus and > 1 ovary, and menstruated in the prior 3 months. ⋯ VMS reporting was 4-fold greater (P = .0005) in women whose urine collections ended without bleeding. In collections with PdG levels suggestive of ovulatory activity according to the work of Kassam et al, VMS are significantly associated with obesity, early perimenopause, and increasing PdG levels. In collections with lower PdG concentrations, VMS are significantly increased with no bleeding, smoking, higher age, physical activity, follicle-stimulating hormone, and luteinizing hormone and are significantly reduced with increasing estrogen concentrations.