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NOT YET RECRUITING
NCT07440043

Relugolix for Endometriosis Associated Pain

Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

View on ClinicalTrials.gov

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.

Official title: An Ambispective, Single-center Observational Study Evaluating the Effectiveness of Relugolix Combination Therapy in Reducing Endometriosis-associated Pain Over 24 Weeks in a Real-world Clinical Setting

Key Details

Gender

FEMALE

Age Range

18 Years - 50 Years

Study Type

OBSERVATIONAL

Enrollment

33

Start Date

2026-02-25

Completion Date

2027-02-28

Last Updated

2026-02-27

Healthy Volunteers

No

Interventions

OTHER

Patients with a diagnosis of endometriosis receiving treatment with Relugolix CT, according to clinical practice,

Collection of clinical, demographic, laboratory, instrumental, and treatment data. Data will be collected from the patients' medical records.