Dydrogesterone treatment for menstrual-cycle regularization in abnormal uterine bleeding – ovulation dysfunction (AUB-O) patients: a prospective observational study
Wei Zhang (CN)
[Zhang] Obstetrics and Gynecology Hospital of Fudan University
Context: The prevalence of abnormal uterine bleeding is estimated to be 11–13% of the general population. Progestin therapy is administered cyclically in order to schedule withdrawal bleeding within the normal MC duration range. Objective: This observational study aimed to evaluate the effect of dydrogesterone on MC regularization and metabolism in the patients with AUB-O. Methods: A prospective, non-interventional, non-controlled, single-arm, post-marketing observational study was conducted in China. Patients: Women aged 16 years or above with menses who had been prescribed dydrogesterone to treat irregular MCs due to the diagnosis of AUB-O were enrolled. Intervention: Patient was treated by dydrogesterone 10mg for cycle regulation treatment, orally taking 1 tablet twice daily, from day16 to day 25 of each cycle, being consecutive at least 3 cycles. Main Outcome Measure: The percentage of patients whose menstrual cycles have returned to normal (defined as 21 days ＜menstrual cycle ≤ 35 days) after three cycles of dydrogesterone treatment. Results: . 114 women were enrolled, which were all AUB-O patients. The mean age was 24.67 (±6.30) years, the mean average days of MCs in the last three months were 63.74±25.47, and the mean average days of menstrual periods in the last three months were 7.13±6.24. Of those who completed treatment, 62/65 patients (95.4%) achieved a regular MC at the end of 3rd circle. There were no statistically significant differences in blood lipid levels (P > 0.05), insulin levels (P > 0.05) or fasting blood glucose (FBG) levels (P > 0.05) before and after the treatment. During the period of treatment, 44/80(55%) subjects had reported biphasic basal body temperature (BBT). Conclusion: Dydrogesterone therapy was effective in achieving MC regularization and has no negative effect on lipid and glucose metabolism.