Treatment of endometriosis-associated pain with linzagolix, an oral gonadotropin-releasing hormone–antagonist: a randomized clinical trial

In a randomized, placebo-controlled, double-blind, dose-ranging trial, once-daily oral doses of 75–200 mg linzagolix, a new gonadotropin-releasing hormone antagonist, significantly reduced endometriosis-associated pain and improved quality of life.

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Volume 114, Issue 1, Pages 44–55

Authors:

Jacques Donnez, M.D., Ph.D., Hugh S. Taylor, M.D., Ph.D., Robert N. Taylor, M.D., Ph.D., Mark D. Akin, M.D., Tatyana F. Tatarchuk, M.D., Dr. Sc., Krzysztof Wilk, M.D., Jean-Pierre Gotteland, Ph.D., Veronique Lecomte, Pharm.D., Elke Bestel, M.D.

Abstract:

Objective

To study the effect of a new investigational oral gonadotropin-releasing hormone antagonist, linzagolix, on endometriosis-associated pain (EAP).

Design

A multinational, parallel group, randomized, placebo-controlled, double-blind, dose-ranging trial.

Setting

Clinical centers.

Patient(s)

Women aged 18–45 years with surgically confirmed endometriosis and moderate-to-severe EAP.

Intervention(s)

The interventions were 50, 75, 100, or 200 mg linzagolix (or matching placebo) administered once daily for 24 weeks.

Main Outcome Measure(s)

The primary endpoint was the number of responders (≥30% reduction in overall pelvic pain) after 12 weeks. Other endpoints included dysmenorrhea, non-menstrual pelvic pain, serum estradiol, amenorrhea, quality of life (QoL) measures, and bone mineral density (BMD).

Result(s)

Compared with placebo, doses ≥ 75 mg resulted in a significantly greater proportion of responders for overall pelvic pain at 12 weeks (34.5%, 61.5%, 56.4%, and 56.3% for placebo, 75, 100, and 200 mg, respectively). A similar pattern was seen for dysmenorrhea and non-menstrual pelvic pain. The effects were maintained or increased at 24 weeks. Serum estradiol was suppressed, QoL improved, and the rate of amenorrhea increased in a dose-dependent fashion. Mean BMD loss (spine) at 24 weeks was <1% at doses of 50 and 75 mg and increased in a dose-dependent fashion up to 2.6% for 200 mg. BMD of femoral neck and total hip showed a similar pattern.

Conclusion(s)

Linzagolix significantly reduced EAP and improved QoL at doses of 75–200 mg and decreased BMD dose-dependently.

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Fertility and Sterility

Editorial Office, American Society for Reproductive Medicine

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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