Zigler RE, et al. - Researchers investigated the efficacy of ulipristal acetate vs placebo in reducing the number of bleeding days in etonogestrel implant users in a 30-day period. As per outcomes, etonogestrel contraceptive implant users found ulipristal acetate to be well-tolerated with a reduced number of bleeding days.

Methods

• Researchers undertook a single-center, randomized, double-blind, placebo-controlled trial.
• Women aged 18–45 years with an etonogestrel implant in place for greater than 90 days and less than 3 years who reported greater than one bleeding episode in a 24-day period were eligible for participation.
• They provided 15 mg ulipristal acetate to enrolled participants compared with an identical-appearing placebo daily for 7 days.
• Using automated text messaging, participants completed daily bleeding diaries to evaluate whether ulipristal acetate reduces the number of bleeding days as compared with placebo.
• Participant satisfaction with bleeding and the effect of ulipristal acetate on ovulation status were assessed as the secondary outcomes.
• They planned a sample size of 52 per group (n=104), calculated with an effect size of a 30% reduction in bleeding days, SD of 10 days, and dropout of 15%.
• They evaluated the effect of ulipristal acetate on ovulatory potential in a subset with weekly serum progesterone.

Results

• Researchers allocated 65 women to receive 15 mg ulipristal acetate (n=32) or placebo (n=33) daily for 7 days from May 2017 to January 2018.
• The groups were similar regarding demographic characteristics.
• Findings revealed 5 fewer days of bleeding over a 30-day reference period after treatment among women receiving ulipristal acetate (P=.002).
• Women in the ulipristal acetate group vs the placebo group were more satisfied with their bleeding profile at the end of the 30-day follow-up period (87.5% vs 60%, respectively; P < .001).
• In a subset of each group, serum progesterone levels were nonovulatory (placebo group range: less than 0.2–1.3 ng/mL; ulipristal acetate group range: less than 0.2–4.4 ng/mL).