Short-Term Treatment of Bothersome Bleeding for Etonogestrel Implant Users Using
a 14-Day Oral Contraceptive Pill Regimen: A Randomized Controlled Trial.
Author(s): Guiahi M(1), McBride M, Sheeder J, Teal S.
Affiliation(s): Author information:
(1)Department of Obstetrics and Gynecology, Section of Family Planning,
University of Colorado Anschutz Medical Center, Aurora, Colorado.
Publication date & source: 2015, Obstet Gynecol. ,
OBJECTIVE: To understand whether using oral contraceptive pills (OCPs) results in
temporary interruption of bleeding for etonogestrel contraceptive implant users
during a 14-day course.
METHODS: In this double-blind trial, we randomly assigned etonogestrel implant
users reporting 7 consecutive days or more of bothersome bleeding to receive 14
pills of study drug (150 microgram levonorgestrel and 30 microgram ethinyl
estradiol combined OCPs) or an identical-appearing placebo. The primary outcome
was the proportion of women in each group who stopped bleeding during therapy and
continued to report no bleeding at the end of therapy. Prespecified secondary
outcomes were number of days until temporary interruption of bleeding occurred,
number of days without bleeding during therapy, and number of days to recurrence
of bleeding after discontinuation of therapy. We hypothesized that temporary
interruption of bleeding would occur in 80% of the treatment group compared with
20% in the control group; using 80% power, we needed a sample size of 26 women.
We performed intent-to-treat analysis.
RESULTS: From November 2013 through December 2014, 66 women were screened and 32
were randomized: OCPs (n=16) or placebo (n=16). The majority was young, Caucasian
women with reported bleeding as extremely or very annoying; groups had similar
baseline characteristics. Participants randomized OCPs were more likely (14 of 16
[87.5%±16.2%] compared with six of 16 [37.5%±23.7%]) to have a temporary
interruption of bleeding during the study drug period (odds ratio 11.7, 95%
confidence interval 1.9-70.2). Of women in the OCP arm who had a temporary
interruption, 85.7% had bleeding recurrence within 10 days after treatment.
CONCLUSION: Bothersome bleeding in etonogestrel contraceptive implant users will
usually stop with 14-day OCP treatment, but bleeding most often resumes within
days of treatment cessation.
CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov,
NCT01968135.
LEVEL OF EVIDENCE: I.
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