Treatment of endometriosis-associated pain with linzagolix, an oral gonadotropin-releasing hormone–antagonist: a randomized clinical trial
| Autor: | Jacques Donnez, Veronique Lecomte, Jean-Pierre Gotteland, Hugh S. Taylor, Mark D. Akin, Krzysztof Wilk, Tatyana F. Tatarchuk, Elke Bestel, Robert N. Taylor |
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| Rok vydání: | 2020 |
| Předmět: |
Adult
0301 basic medicine medicine.medical_specialty Adolescent Carboxylic Acids Endometriosis Urology Administration Oral Pelvic Pain Hormone antagonist Placebo law.invention Gonadotropin-Releasing Hormone Young Adult 03 medical and health sciences Hormone Antagonists 0302 clinical medicine Double-Blind Method Randomized controlled trial law medicine Clinical endpoint Humans Organic Chemicals Uterine Diseases 030219 obstetrics & reproductive medicine Dose-Response Relationship Drug business.industry Pelvic pain Obstetrics and Gynecology Middle Aged medicine.disease Clinical trial Pyrimidines Treatment Outcome 030104 developmental biology Reproductive Medicine Female Amenorrhea Chronic Pain medicine.symptom business |
| Zdroj: | Fertility and Sterility. 114:44-55 |
| ISSN: | 0015-0282 |
| DOI: | 10.1016/j.fertnstert.2020.02.114 |
| Popis: | 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 Conclusion(s) Linzagolix significantly reduced EAP and improved QoL at doses of 75–200 mg and decreased BMD dose-dependently. Clinical Trial Registration Number NCT02778399 |
| Databáze: | OpenAIRE |
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