Effects of a preovulatory single low dose of mifepristone on ovarian function

Objectives To investigate the effect of a single low dose of mifepristone on ovarian function, when administered in the preovulatory period. Methods Healthy women with regular menstrual cycles were studied during two consecutive menstrual cycles. Either mifepristone or placebo was given in a randomized double-blind order when the leading follicle reached a diameter between 15 and 17 mm. Daily ultrasound and serum hormone measurements were obtained until follicular collapse. Statistical analysis was performed using Wilcoxon signed-rank test. Results Eight women entered the study, although one woman had to be excluded afterwards from analysis because her LH surge had already appeared on the day of treatment. The LH surge was delayed from day 14 to 17 (P = 0.01). Mifepristone caused a 3-day delay in follicular collapse, occurring on day 16 in control cycles and on day 19 in mifepristone treatment cycles (P = 0.02). The median cycle length was 26 days in control cycles and 30 days in mifepristone treatment cycles (P = 0.03). Progesterone measurement 7 days after follicular collapse did not differ significantly between both cycles. Conclusions A single 10-mg dose of mifepristone administered during the preovulatory phase of the cycle delays the LH surge and postpones ovulation

Cost-Effectiveness of perioperative Vaginally Administered estrogen in postmenopausal women undergoing prolapse surgery (EVA trial):study protocol for a multicenter double-blind randomized placebo-controlled trial

BACKGROUND: Surgery for pelvic organ prolapse (POP) is associated with high recurrence rates. The costs associated with the treatment of recurrent POP are huge, and the burden from women who encounter recurrent POP, negatively impacts their quality of life. Estrogen therapy might improve surgical outcome for POP due to its potential beneficial effects. It is thought that vaginal estrogen therapy improves healing and long-term maintenance of connective tissue integrity. Hence, this study aims to evaluate the cost-effectiveness of perioperative vaginal estrogen therapy in postmenopausal women undergoing POP surgery. METHODS: The EVA trial is a multi-center double-blind randomized placebo-controlled trial conducted in the Netherlands comparing the effectiveness and costs-effectiveness of vaginal estrogen therapy. This will be studied in 300 postmenopausal women undergoing primary POP surgery, with a POP-Q stage of ≥ 2. After randomization, participants administer vaginal estrogen cream or placebo cream from 4 to 6 weeks preoperative until 12 months postoperative. The primary outcome is subjective improvement of POP symptoms at 1 year follow-up, measured with the Patient Global Impression of Improvement (PGI-I) scale. Secondary outcomes are POP-Q anatomy in all compartments, re-interventions, surgery related complications, general and disease specific quality of life, sexual function, signs and complaints of vaginal atrophy, vaginal pH, adverse events, costs, and adherence to treatment. Follow up is scheduled at 6 weeks, 6 months and 12 months postoperative. Data will be collected using validated questionnaires and out-patient visits including gynecological examination performed by an independent gynecologist. DISCUSSION: This study investigates whether perioperative vaginal estrogen will be cost-effective in the surgical treatment of POP in postmenopausal women. It is hypothesized that estrogen therapy will show a reduction in recurrent POP symptoms and a reduction in reoperations for POP, with subsequent improved quality of life among women and cost savings. Trial registrationNetherlands Trial Registry: NL6853; registered 19-02-2018, https://www.trialregister.nl/trial/6853. EudraCT: 2017-003144-21; registered: 24-07-2017. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12905-021-01587-9