Relugolix for Endometriosis Associated Pain

Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study ID
NCT07440043
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

First listed
Feb 27, 2026
Start date
Feb 25, 2026
Status verified
Feb 2026
Primary completion
Dec 25, 2026
Completion
Feb 28, 2027

Study Design

Enrollment
33 participants (estimated)

Primary Outcome Measure

Evaluation of reduction of endometriosis associated pelvic pain [ Time Frame: 24 weeks ]

Central Contacts

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