Ethinylestradiol 20 μg/drospirenone 3 mg in a flexible extended regimen for the management of endometriosis-associated pelvic pain: a randomized controlled trial

A flexible extended regimen of ethinylestradiol 20 mg/drospirenone 3 mg (FlexibleMIB) improved endometriosis-associated pelvic pain and was well tolerated. FlexibleMIB is a new alternative for treating endometriosis.

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Volume 108, Issue 5, Pages 798–805

Authors:

Tasuku Harada, M.D., Saori Kosaka, M.D., Joerg Elliesen, M.D., Masanobu Yasuda, Makoto Ito, Mikio Momoeda, M.D.

Abstract:

Objective

To investigate the efficacy 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).

Design

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.

Setting

Thirty-two centers.

Patient(s)

A total of 312 patients with endometriosis.

Intervention(s)

Patients were randomized to FlexibleMIB, placebo, or dienogest. The FlexibleMIB and placebo arms received 1 tablet per day continuously for 120 days, 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.

Main Outcome Measure(s)

Absolute change in the most severe EAPP based on visual analog scale scores from the baseline observation phase to the end of the double-blind treatment phase.

Result(s)

Compared with placebo, FlexibleMIB significantly reduced 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 reduced the size of endometriomas.

Conclusion(s)

FlexibleMIB improved EAPP and was well tolerated, suggesting it may be a new alternative for managing endometriosis.

Clinical Trials Registration Number

NCT01697111.


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Fertility and Sterility® is an international journal for obstetricians, gynecologists, reproductive endocrinologists, urologists, basic scientists and others who treat and investigate problems of infertility and human reproductive disorders. The journal publishes juried original scientific articles in clinical and laboratory research relevant to reproductive endocrinology, urology, andrology, physiology, immunology, genetics, contraception, and menopause. Fertility and Sterility® encourages and supports meaningful basic and clinical research, and facilitates and promotes excellence in professional education, in the field of reproductive medicine.

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