Observational Study
Copyright ©The Author(s) 2020. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Cases. Aug 6, 2020; 8(15): 3259-3266
Published online Aug 6, 2020. doi: 10.12998/wjcc.v8.i15.3259
Dydrogesterone treatment for menstrual-cycle regularization in abnormal uterine bleeding – ovulation dysfunction patients
Lu Wang, Hai-Yun Guan, He-Xia Xia, Xiu-Ying Chen, Wei Zhang
Lu Wang, Hai-Yun Guan, He-Xia Xia, Xiu-Ying Chen, Wei Zhang, Department of Reproductive Endocrinology, Obstetrics and Gynecology Hospital of Fudan University, Shanghai 200011, China
Author contributions: Wang L and Guan HY performed the majority of experiments and wrote the manuscript; Xia HX designed the study and corrected the manuscript; Chen XY contributed to data analysis; Zhang W was responsible for designing and performing the study, manuscript reviewing and approval of the final version; all authors have read and approve the final manuscript.
Supported by Abbott (32F Crio's Plaza, 388 West Nanjing Road, Shanghai, China), No. A14-390.
Institutional review board statement: The study protocol was approved by the Ethics Committee, Obstetrics and Gynecology Hospital of Fudan University (Shanghai).
Informed consent statement: Written informed consent was obtained from each participant.
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).
Data sharing statement: No additional data are available.
STROBE statement: The authors have read the STROBE Statement-checklist of items, and the manuscript was prepared and revised according to the STROBE Statement-checklist of items.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Corresponding author: Wei Zhang, MD, Professor, Department of Reproductive Endocrinology, Obstetrics and Gynecology Hospital of Fudan University, No. 419 Fangxie Road, Shanghai 200011, China. zhangwei623@hotmail.com
Received: March 4, 2020
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
ARTICLE HIGHLIGHTS
Research background

Abnormal uterine bleeding - ovulation dysfunction (AUB-O) is caused by the deficiency of progesterone and the unopposed secretion of estrogens, leading to a sustained endometrial proliferation without progesterone-withdrawal-induced shedding. Dydrogesterone has shown significant efficacy in the treatment of irregular menstrual cycle due to AUB-O.

Research motivation

Although increasing evidence showed the good efficacy of dydrogesterone in menstrual disorders, few studies are available focusing its efficacy for AUB-O patients, especially in China where synthetic progestins are commonly prescribed for hemostasis and menstrual cycle regulation.

Research objectives

Our study aimed to evaluate the effects of dydrogesterone on menstrual-cycle (MC) regularization and metabolism in the patients with AUB-O.

Research methods

Women aged 16 years or above with AUB-O were treated with dydrogesterone orally 1 tablet (10 mg) twice daily from day 16 to 25 of each cycle and consecutively for at least 3 cycles, the primary objective was to observe the percentage of patients whose MCs returned to normal (defined as 21 d < MC ≤ 35 d) after treatment.

Research results

Seventy-two (80.9%) of the 89 patients achieved a regular MC at the end of the 3rd circle treatment, and the level of androgen, including testosterone and dehydro-epiandrosterone sulfate, declined significantly (P = 0.01 and 0.031, respectively).

Research conclusions

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

Research perspectives

This observational study suggested that dydrogesterone was effective and safe for the treatment of AUB-O in Chinese women. More studies with a larger sample size, longer follow-up and generally accepted nomenclature of menstrual disorders would be highly desirable.