Harada T, et al. - A randomized controlled trial is performed to research the effectiveness and safety of ethinylestradiol 20 μg/drospirenone 3 mg in a flexible extended regimen (FlexibleMIB) compared with placebo to treat endometriosis-associated pelvic pain (EAPP). The outcome of this study suggests that the FlexibleMIB improved EAPP and was well tolerated and they recommending that it may be a new option for managing endometriosis.
- For this research, they designed a phase 3, randomized, double-blind, placebo-controlled, parallel-group study, consisting of a 24-week double-blind treatment phase followed by a 28-week open-label extension phase with an unblinded reference arm.
- This study was conducted at 32 centers.
- A total of 312 patients with endometriosis were enrolled in this study.
- All the participants were randomized to FlexibleMIB, placebo, or dienogest.
- The FlexibleMIB and placebo arms received 1 tablet per day continuously for 4 months, with a 4-day tablet-free interval either after 120 days or after ≥ 3 consecutive days of spotting and/or bleeding on days 25-120.
- After 24 weeks, placebo recipients were changed to FlexibleMIB. Patients randomized to dienogest received 2 mg/d for 52 weeks in an unblinded reference arm.
- Compared with placebo, FlexibleMIB significantly decreased the most severe EAPP (mean difference in visual analog scale score: -26.3 mm).
- FlexibleMIB also improved other endometriosis-associated pain and gynecologic findings and decreased the size of endometriomas.
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