NCT07440043

Relugolix for Endometriosis Associated Pain

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 33 (estimated)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Endometriosis is a chronic, estrogen-dependent condition frequently associated with pelvic pain and impaired quality of life. Despite available hormonal treatments, unmet clinical needs remain in terms of long-term efficacy and tolerability. Relugolix combination therapy (CT), an oral GnRH receptor antagonist combined with estradiol and norethisterone acetate, has shown efficacy in randomized trials, but real-world data are limited. The RELAX study is a single-center, ambispective observational study evaluating the effectiveness of relugolix CT in routine clinical practice. Women aged 18-50 years with laparoscopically or radiologically confirmed endometriosis receiving relugolix CT will be included. Both retrospective and prospective data will be collected. The primary objective is to assess the change from baseline in chronic pelvic pain measured by the Visual Analog Scale (VAS) after 24 weeks of treatment. Secondary outcomes include changes in dyspareunia, dyschezia, and dysuria; the proportion of patients achieving ≥30% and ≥50% reduction in VAS pain score; changes in transvaginal ultrasound findings; patient satisfaction; and safety. This study aims to provide real-world evidence to support clinical decision-making in the management of endometriosis-associated pain.

Conditions

• Endometriosis
• Endometriosis-related Pain
• Pelvic Pain Syndrome

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-02-25
• Primary completion: 2026-12-25
• Completion: 2027-02-28
• First posted: 2026-02-27
• Last updated: 2026-02-27