Tamoxifen for the treatment of breakthrough bleeding with the etonogestrel implant: a randomized controlled trial

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• 作者：Katharine B. Simmons^a ; ¹ ; ^{simmonka@ohsu.edu} ; Alison B. Edelman^a ; Rongwei Fu^b ; ^c ; Jeffrey T. Jensen^a
• 关键词：Etonogestrel implant ; Breakthrough bleeding ; Contraception ; Tamoxifen
• 刊名：Contraception
• 出版年：2017
• 出版时间：February 2017
• 年：2017
• 卷：95
• 期：2
• 页码：198-204
• 全文大小：771 K
• 卷排序：95

文摘

The etonogestrel (ENG) subdermal implant can cause frequent breakthrough bleeding in some users. The objective of this study was to evaluate whether a short course of tamoxifen reduces bleeding/spotting days compared to placebo in ENG implant users.Study designIn this double-blind trial, we randomized ENG implant users with frequent or prolonged bleeding or spotting to tamoxifen 10 mg or placebo twice daily for 7 days, to be started after 3 consecutive days of bleeding/spotting. Treatment was repeated as needed up to three times in 180 days. Subjects completed a daily text message bleeding diary. A sample size of 56 provided 80% power to detect a difference of 6 days of bleeding/spotting per 30 days by two-sample t test. Ovulation was monitored by urinary metabolites of progesterone.ResultsFrom March 2014 to February 2015, 56 women enrolled. Fifty-one completed at least 30 days of follow up, and 34 completed 180 days. Compared to women randomized to placebo, women randomized to tamoxifen reported 5 fewer days of bleeding/spotting over 30 days (95% confidence interval [CI] −9.9 to −0.05, p=.05), and 15.2 more continuous bleeding-free days (95% CI 2.8–27.5 days, p=.02) after first use of study drug. Conclusions could not be drawn after 30 days due to higher-than-expected dropout. No ovulation was detected.ConclusionFirst use of tamoxifen by ENG implant users reduces bleeding/spotting days and provides a longer cessation of bleeding/spotting than placebo, without compromising ovulation suppression. Further study is needed to determine whether this effect is maintained with repeat use.ImplicationsWomen with frequent ENG implant-related breakthrough bleeding may experience a reduction in bleeding/spotting days and an increase in continuous bleeding-free days in the month following first use of tamoxifen. This short course of tamoxifen was well tolerated with bleeding cessation noted within a median of 5 days.