Obstetrics and gynecology · 2015
Short-Term Treatment of Bothersome Bleeding for Etonogestrel Implant Users Using a 14-Day Oral Contraceptive Pill Regimen: A Randomized Controlled Trial.
Сравнительное исследованиеСтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Guiahi Maryam, McBride Madeline, Sheeder Jeanelle, Teal Stephanie
Аннотация
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.
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.