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.
Comments
I am part of a team currently working on a cochrane review on the benefits of GnRH antagonists on the treatment for endometriotic pain. Your study has been selected for the meta-analysis. Following discussions with our statistician we would like to ask the authors whether they could provide us with final scores (as appose to the change in score or difference from placebo published in the paper) for dysmenorrhoea, non menstrual pelvic pain, dyschezia, difficulty in doing daily activity and dyspareunia. This would help us enormously with the data analysis in the final meta-analysis.
Many thanks
Hi, I am sending a second request regarding obtaining further information on the final scores on dysmenorrhoea, non menstrual pelvic pain, dyschezia, difficutly in doing daily activity and dyspareunia on the above article in order for us to perform a meta-analysis with other papers on the effectiveness of GnRH antagonists on endometriosis. Many thanks