TY - JOUR
T1 - Tamoxifen for the prevention of unscheduled bleeding in new users of the levonorgestrel 52-mg intrauterine system
T2 - a randomized controlled trial
AU - Cohen, Megan A.
AU - Simmons, Katharine B.
AU - Edelman, Alison B.
AU - Jensen, Jeffrey T.
N1 - Funding Information:
Financial support: Grant support for this research was provided by the Society of Family Planning (SFPRF10-T06; PI: Cohen). The use of REDCap, data capture system, was supported by National Center for Advancing Translational Sciences of the National Institutes of Health under award number UL1TR0002369. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Author disclosures: M. Cohen has nothing to disclose. A. Edelman is a consultant for World Health Organization, Gynuity Health Projects, Agile Therapeutics, HRA Pharma and Exeltis; Nexplanon trainer for Merck and the recipient of a Merck investigator-initiated grant; and author for UpToDate. OHSU has received research support from HRA Pharma. J. Jensen has received payments for consulting from Abbvie, Cooper Surgical, Bayer Healthcare, Merck, Sebela and the Population Council. OHSU has received research support from Abbvie, Bayer Healthcare, Daré, Estetra SPRL, Medicines360, Merck and Sebela. These companies and organizations may have a commercial or financial interest in the results of this research and technology. These potential conflicts of interest for A. Edelman and J. Jensen have been reviewed and managed by OHSU. K. Simmons is a Nexplanon trainer for Merck.
Publisher Copyright:
© 2019 Elsevier Inc.
PY - 2019/11
Y1 - 2019/11
N2 - Objective: To determine if a course of oral tamoxifen initiated following placement of a levonorgestrel 52-mg intrauterine system (IUS) reduces bleeding/spotting days over 30 days. Study design: In this single-center, double-blind, placebo-controlled trial, we recruited women ages 15–45 years initiating the levonorgestrel 52-mg IUS. We randomized eligible women to tamoxifen 10 mg or placebo twice daily for 7 days starting 21 days after levonorgestrel 52-mg IUS insertion. Participants tracked bleeding/spotting days via daily electronic diaries for 30 days after starting drug treatment. We assessed participant satisfaction with their bleeding pattern and the IUS using a visual analog scale (0–100 mm). A sample size of 42 provided 80% power to detect a difference of 7 bleeding/spotting days in 30 days by two-sample t test, accounting for an expected 20% dropout rate. Results: From September 2016 to January 2018, 42 women enrolled. A total of 34 women provided complete bleeding/spotting data, and 30 women provided satisfaction data. Mean bleeding/spotting days over 30 days did not differ between tamoxifen (12.0±5.8 days) and placebo users (16.8±9.0 days), p=.08. We found no significant differences in mean satisfaction with bleeding profiles (51 mm tamoxifen vs. 59 mm placebo, p=.48) or with the IUS (83 mm vs. 75 mm, p=.36) between groups. Both groups reported similar rates of adverse events, with no serious adverse events reported. Conclusion: A course of oral tamoxifen did not improve early breakthrough bleeding or satisfaction in new users of the levonorgestrel 52-mg IUS. Implications: Although tamoxifen treatment caused a trend toward modest bleeding/spotting day reduction in new levonorgestrel 52-mg IUS users, bleeding satisfaction did not improve. Future studies of tamoxifen treatment for IUS-related bleeding issues may be best targeted toward users with ongoing bleeding irregularities or lower-dose IUS products which cause more bleeding irregularities.
AB - Objective: To determine if a course of oral tamoxifen initiated following placement of a levonorgestrel 52-mg intrauterine system (IUS) reduces bleeding/spotting days over 30 days. Study design: In this single-center, double-blind, placebo-controlled trial, we recruited women ages 15–45 years initiating the levonorgestrel 52-mg IUS. We randomized eligible women to tamoxifen 10 mg or placebo twice daily for 7 days starting 21 days after levonorgestrel 52-mg IUS insertion. Participants tracked bleeding/spotting days via daily electronic diaries for 30 days after starting drug treatment. We assessed participant satisfaction with their bleeding pattern and the IUS using a visual analog scale (0–100 mm). A sample size of 42 provided 80% power to detect a difference of 7 bleeding/spotting days in 30 days by two-sample t test, accounting for an expected 20% dropout rate. Results: From September 2016 to January 2018, 42 women enrolled. A total of 34 women provided complete bleeding/spotting data, and 30 women provided satisfaction data. Mean bleeding/spotting days over 30 days did not differ between tamoxifen (12.0±5.8 days) and placebo users (16.8±9.0 days), p=.08. We found no significant differences in mean satisfaction with bleeding profiles (51 mm tamoxifen vs. 59 mm placebo, p=.48) or with the IUS (83 mm vs. 75 mm, p=.36) between groups. Both groups reported similar rates of adverse events, with no serious adverse events reported. Conclusion: A course of oral tamoxifen did not improve early breakthrough bleeding or satisfaction in new users of the levonorgestrel 52-mg IUS. Implications: Although tamoxifen treatment caused a trend toward modest bleeding/spotting day reduction in new levonorgestrel 52-mg IUS users, bleeding satisfaction did not improve. Future studies of tamoxifen treatment for IUS-related bleeding issues may be best targeted toward users with ongoing bleeding irregularities or lower-dose IUS products which cause more bleeding irregularities.
KW - Contraception
KW - Levonorgestrel intrauterine system
KW - Tamoxifen
KW - Unscheduled bleeding
UR - http://www.scopus.com/inward/record.url?scp=85068769063&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85068769063&partnerID=8YFLogxK
U2 - 10.1016/j.contraception.2019.06.009
DO - 10.1016/j.contraception.2019.06.009
M3 - Article
C2 - 31226322
AN - SCOPUS:85068769063
SN - 0010-7824
VL - 100
SP - 391
EP - 396
JO - Contraception
JF - Contraception
IS - 5
ER -