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

Abstract

OBJECTIVE:

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 DESIGN:

In 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.

RESULTS:

From 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.

CONCLUSION:

First 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.

IMPLICATIONS:

Women 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.

• Authors: Katharine B Simmons, Alison B Edelman, Rongwei Fu, Jeffrey T Jensen
• Journal: Contraception (Contraception) Vol. 95 Issue 2 Pg. 198-204 (Feb 2017) ISSN: 1879-0518 [Electronic] United States
• PMID: 27725164 (Publication Type: Journal Article, Randomized Controlled Trial)
• Copyright: Copyright © 2017 Elsevier Inc. All rights reserved.

Chemical References

• Contraceptive Agents, Female
• Drug Implants
• Placebos
• Tamoxifen
• etonogestrel
• Progesterone
• Desogestrel

Topics

• Adolescent
• Adult
• Contraceptive Agents, Female
• Desogestrel (administration & dosage, adverse effects)
• Double-Blind Method
• Drug Implants
• Female
• Humans
• Metrorrhagia (chemically induced, drug therapy)
• Middle Aged
• Ovulation (urine)
• Placebos
• Progesterone (urine)
• Tamoxifen (therapeutic use)
• Uterine Hemorrhage
• Young Adult