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Relugolix for Endometriosis Associated Pain

NCT07440043 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 33

Last updated 2026-02-27

No results posted yet for this study

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.

Conditions

  • Endometriosis
  • Endometriosis-related Pain
  • Pelvic Pain Syndrome

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.

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Cristiano Rossitto · Fondazione Policlinico Universitario A. Gemelli, IRCCS

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-25
Primary Completion
2026-12-25
Completion
2027-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07440043 on ClinicalTrials.gov