Relugolix, a novel oral gonadotropin-releasing hormone antagonist, in the treatment of pain symptoms associated with uterine fibroids: a randomized, placebo-controlled, phase 3 study in Japanese women

This first randomized study in premenopausal women with uterine fibroid–associated pain showed that oral once-daily treatment with 40 mg relugolix significantly reduced pain symptoms and was well tolerated.

0
0

Volume 112, Issue 5, Pages 922–929.e2

Authors:

Yutaka Osuga, M.D., Ph.D., Kazuaki Enya, M.Pharm., Kentarou Kudou, M.Sc., Hiroshi Hoshiai, M.D., Ph.D.

Abstract:

Objective

To investigate the efficacy and safety of the oral gonadotropin-releasing hormone receptor antagonist, relugolix, in patients experiencing uterine fibroid–associated pain.

Design

Phase 3, multicenter, randomized, double-blind, placebo-controlled study.

Setting

Centers.

Patient(s)

Premenopausal Japanese women (N = 65) experiencing moderate-to-severe uterine fibroid–associated pain with a maximum Numerical Rating Scale (NRS) score of ≥4 were randomized and completed the study.

Intervention(s)

Once-daily 40 mg relugolix (n = 33) or placebo (n = 32) for 12 weeks.

Main Outcome Measure(s)

Primary end point: proportion of patients with a maximum NRS score of ≤1 during the 28-day period before the final dose of study drug. Secondary end points: proportion of patients with no pain (NRS = 0) and percentage of days without pain during the 28-day period before the final dose of study drug; adverse events.

Result(s)

More patients receiving relugolix versus placebo achieved a maximum NRS score of ≤1 during the 28-day period before the final dose of study drug (57.6% vs. 3.1%). Similarly, more patients receiving relugolix versus placebo achieved a maximum NRS score of 0 (48.5% vs. 3.1%) and experienced more days without pain (96.4% vs. 71.4%). More patients receiving relugolix versus placebo experienced treatment-emergent adverse events (TEAEs; 87.9% vs. 56.3%); however, the rate of treatment discontinuation was low and not different between groups. Most TEAEs were mild to moderate in intensity. TEAEs (≥10%) included hot flush, metrorrhagia, hyperhidrosis, and menorrhagia, consistent with relugolix's mechanism of action, and viral upper respiratory tract infection.

Conclusion(s)

Relugolix improved uterine fibroid–associated pain and was well tolerated.

Clinical Trial Registration Numbers

ClinicalTrials.govNCT02655224; JAPIC Clinical Trial Information: JapicCTI-163127.


Read the full text here.

Go to the profile of Fertility and Sterility

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.

No comments yet.