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Relugolix for Endometriosis Associated Pain
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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
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.