Published online Aug 6, 2020. doi: 10.12998/wjcc.v8.i15.3259
Peer-review started: March 4, 2020
First decision: April 14, 2020
Revised: June 2, 2020
Accepted: June 23, 2020
Article in press: June 23, 2020
Published online: August 6, 2020
Processing time: 154 Days and 21.8 Hours
Dydrogesterone has shown significant efficacy in treatment of irregular menstrual cycle due to abnormal uterine bleeding - ovulation dysfunction (AUB-O), but there were few relevant studies. This observational study was designed to evaluate the effectiveness of dydrogesterone for the treatment of Chinese patients with AUB-O.
To evaluate the effects of dydrogesterone on menstrual-cycle (MC) regularization and metabolism in the patients with AUB-O.
A prospective, non-interventional, single-arm, post-marketing observational study was conducted. Chinese women aged 16 years or above with AUB-O who had been prescribed dydrogesterone were enrolled. The patients were treated with dydrogesterone 10 mg from day 16 to day 25 of each cycle, consecutively for at least 3 cycles. The main outcome was defined as the percentage of patients whose MCs returned to normal (defined as 21 d < menstrual cycle ≤ 35 d) after three cycles of dydrogesterone treatment.
One hundred and fourteen women with AUB-O were enrolled in the present study. Of 89 patients who completed treatment, 72 (80.9%) achieved a regular MC at the end of the 3rd circle. The level of androgen, including testosterone and dehydroepiandrosterone sulfate, declined significantly (P = 0.01 and 0.031, respectively), whereas other hormone levels remained steady. During the treatment, 44/80 (55.0%) subjects in the per-protocol set had reported biphasic basal body temperature.
Dydrogesterone therapy was effective in achieving MC regularization for Chinese patients with AUB-O.
Core tip: The normal interval of menstrual-cycle is typically 21 to 35 d and duration of normal menstrual flow is generally 5 d. Abnormal uterine bleeding continues to pose significant physical and financial burdens on patients. In this study, we analyzed the data of 114 women with abnormal uterine bleeding - ovulation dysfunction (AUB-O) who were treated with dydrogesterone 10 mg from day 16 to day 25 of each cycle, consecutively for at least 3 cycles. It is suggested that dydrogesterone therapy was effective in achieving menstrual-cycle regularization for Chinese patients with AUB-O.