Clinical Trial

Relugolix for Endometriosis Associated Pain

Study acronym: RELAX
Not Yet Recruiting
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Summary
Endometriosis is a chronic, estrogen-dependent condition frequently associated with pelvic pain and reduced quality of life. Relugolix combination therapy (CT), an oral GnRH receptor antagonist-based treatment, has demonstrated efficacy in randomized clinical trials, but real-world data remain limited. The RELAX study is a single-center, ambispective observational study evaluating the effectiveness of relugolix CT in reducing endometriosis-associated pain over 24 weeks in routine clinical practice. The primary endpoint is the change from baseline in pelvic pain measured by the Visual Analog Scale (VAS). Secondary outcomes include changes in pain-related symptoms, ultrasonographic findings, patient satisfaction, and safety.
Trial Details
NCT Number NCT07440043
Lead Sponsor Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions Endometriosis, Endometriosis-related Pain, Pelvic Pain Syndrome
Enrollment 33 participants
Start Date 2026-02-25
Primary Completion 2026-12-25 (estimated)
Study Completion 2027-02-28 (estimated)
Updated on ClinicalTrials.gov 2026-02-27