Clomiphene citrate as a new modality in management of vaginal bleeding with depomedroxyprogesterone acetate (DMPA): A randomized controlled trial

IF 2.1 4区 医学 Q4 BIOCHEMISTRY & MOLECULAR BIOLOGY Steroids Pub Date : 2024-04-16 DOI:10.1016/j.steroids.2024.109425
Kareem Shaheen , Hany H. Kamel , Enas Mostafa Mohammed , Ahmed Hashim Mohammed , Sileem Ahmed Sileem , Mahmoud Fouad , Zainab Shehata Sayd , Mohamed E. ElHodiby
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Abstract

Background

Depo-medroxyprogesterone acetate (DMPA) functions as a contraceptive method by inhibiting the secretion of gonadotropins, which prevents follicular maturation and ovulation, as well as thinning of the endometrium leading to unscheduled vaginal bleeding and subsequent discontinuation of DMPA. Our study aimed to evaluate the efficacy and safety of clomiphene citrate (CC) in stopping bleeding among DMPA users.

Materials and Methods

We randomly assigned 200 DMPA users using a computer-generated random numbers table in a 1:1 ratio to one of two groups; the study group, which received CC at a dose of 50 mg twice daily for five days (n = 100), and the control group, which received a placebo for five days (n = 100). Our primary outcome measure was the onset and duration of bleeding cessation. Secondary outcomes included endometrial thickness, recurrence of vaginal bleeding, and any reported side effects associated with CC use.

Results

Clomiphene citrate significantly resulted in early cessation of vaginal bleeding in 83 % of the patients, which continued for three months of follow-up. In addition, the recurrence of vaginal bleeding was significantly reduced in the CC group compared to the control group (11 % vs. 67 %; p < 0.001). Endometrial thickness was significantly greater in the CC group than in the control group (p < 0.001). Breast tenderness was more frequently reported in the study group, with no difference in dyspareunia between the two groups.

Conclusions

Clomiphene citrate is effective in controlling bleeding among DMPA users. Further studies are encouraged to confirm our findings.

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枸橼酸氯米芬作为醋酸去甲地孕酮(DMPA)治疗阴道出血的新方法:随机对照试验
背景醋酸去羟孕酮(DMPA)通过抑制促性腺激素的分泌,阻止卵泡成熟和排卵,以及子宫内膜变薄导致计划外阴道出血和随后停用DMPA,从而起到避孕的作用。我们的研究旨在评估枸橼酸氯米芬(CC)对 DMPA 使用者止血的有效性和安全性。材料和方法我们使用计算机生成的随机数字表,按 1:1 的比例将 200 名 DMPA 使用者随机分配到两组中的一组;研究组和对照组各 100 人,研究组服用 CC,剂量为 50 毫克,每天两次,连续服用 5 天;对照组服用安慰剂,连续服用 5 天。我们的主要结果指标是出血停止的起始时间和持续时间。次要结果包括子宫内膜厚度、阴道出血复发率以及与使用 CC 相关的任何副作用。此外,与对照组相比,CC 组阴道出血复发率明显降低(11% 对 67%;p <0.001)。CC组的子宫内膜厚度明显高于对照组(p <0.001)。结论枸橼酸克罗米芬能有效控制 DMPA 使用者的出血。我们鼓励开展更多的研究来证实我们的发现。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Steroids
Steroids 医学-内分泌学与代谢
CiteScore
5.10
自引率
3.70%
发文量
120
审稿时长
73 days
期刊介绍: STEROIDS is an international research journal devoted to studies on all chemical and biological aspects of steroidal moieties. The journal focuses on both experimental and theoretical studies on the biology, chemistry, biosynthesis, metabolism, molecular biology, physiology and pharmacology of steroids and other molecules that target or regulate steroid receptors. Manuscripts presenting clinical research related to steroids, steroid drug development, comparative endocrinology of steroid hormones, investigations on the mechanism of steroid action and steroid chemistry are all appropriate for submission for peer review. STEROIDS publishes both original research and timely reviews. For details concerning the preparation of manuscripts see Instructions to Authors, which is published in each issue of the journal.
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