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. 2020 Aug 6;8(15):3259-3266.
doi: 10.12998/wjcc.v8.i15.3259.

Dydrogesterone treatment for menstrual-cycle regularization in abnormal uterine bleeding - ovulation dysfunction patients

Lu Wang  1 , Hai-Yun Guan  1 , He-Xia Xia  1 , Xiu-Ying Chen  1 , Wei Zhang  2
Affiliations

Dydrogesterone treatment for menstrual-cycle regularization in abnormal uterine bleeding - ovulation dysfunction patients

Lu Wang et al. World J Clin Cases. .

Abstract

Background: 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.

Aim: To evaluate the effects of dydrogesterone on menstrual-cycle (MC) regularization and metabolism in the patients with AUB-O.

Methods: 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.

Results: 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.

Conclusion: Dydrogesterone therapy was effective in achieving MC regularization for Chinese patients with AUB-O.

Keywords: Abnormal uterine bleeding-ovulation dysfunction; Dehydroepiandrosterone sulfate; Dydrogesterone; Hormone; Menstrual cycle; Testosterone.

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Conflict of interest statement

Conflict-of-interest statement: Dr. Zhang W is the Principle Investigator of the present study, which was supported by grants A14-390 from Abbott (32F Crio's Plaza, 388 West Nanjing Road, Shanghai, China).

Figures

Figure 1
Figure 1
Flow chart of enrollment of subjects. FAS: Full analysis set; SS: Safety set; PPS: Per-protocol set.
See this image and copyright information in PMC

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