Elagolix, an Oral GnRH Antagonist for Endometriosis-Associated Pain: A Randomized Controlled Study
| Autor: | Steven Hass, Kristof Chwalisz, Mahesh Fuldeore, Christopher F. O'Brien, Linda C. Giudice, W. Paul Dmowski, Roland Jimenez, Joshua Burke, Ping Jiang, Bruce R. Carr |
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| Jazyk: | angličtina |
| Rok vydání: | 2013 |
| Předmět: |
medicine.medical_specialty
Clinical Trials and Supportive Activities Urology Endometriosis Reproductive health and childbirth law.invention Paediatrics and Reproductive Medicine Pelvic pain Randomized controlled trial law Clinical Research medicine business.industry Contraception/Reproduction GnRH Antagonist Pain Research Antagonist Neurosciences Evaluation of treatments and therapeutic interventions Elagolix medicine.disease 6.1 Pharmaceuticals Original Article GnRH antagonists medicine.symptom Chronic Pain business Hormone |
| Zdroj: | Journal of Endometriosis and Pelvic Pain Disorders Journal of endometriosis and pelvic pain disorders, vol 5, iss 3 |
| ISSN: | 2284-0273 2284-0265 |
| Popis: | Objective The aim of this study was to estimate the efficacy of elagolix, an oral gonadotropin-releasing hormone (GnRH) antagonist, for the treatment of endometriosis-associated pelvic pain. Methods This was a phase II, randomized, placebo-controlled parallel group study conducted at 37 US centers, consisting of an 8-week double-blind period followed by a 16-week open-label period. Patients were 137 women aged 18 to 49, with laparoscopically confirmed endometriosis and moderate to severe nonmenstrual pelvic pain and dysmenorrhea, who were administered elagolix 150 mg daily or placebo. The primary outcomes of the study were the daily assessment of dysmenorrhea, nonmenstrual pelvic pain and dyspareunia using a modified Biberoglu-Behrman scale. Results During the double-blind period, there were significantly greater mean reductions from baseline to week 8 in dysmenorrhea (-1.13 ± 0.11 vs. −0.37 ± 0.11, pConclusion Elagolix effectively reduced endometriosis-associated pelvic pain over a 24-week period and was well-tolerated. |
| Databáze: | OpenAIRE |
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