Relugolix for Endometriosis Associated Pain

NCT07440043 | Not Yet Recruiting

• 1 other identifier: 26987
• Study Type: observational
• Target: 33
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Evaluation of reduction of endometriosis associated pelvic pain

  To evaluate the reduction of endometriosis-associated pain after a 24-week treatment period with Relugolix CT used according to current clinical practice.

  24 weeks

Secondary Outcomes (4)

• Evaluation of reduction in other endometriosis-associated symptoms

  24 weeks

• Evaluation of reduction in VAS score

  24 weeks

• Changes in ultrasound findings.

  24 weeks

• Evaluation of patient satisfaction

  24 weeks

Interventions

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

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

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a diagnosis of endometriosis who have been receiving treatment with Relugolix CT according to clinical practice for at least one month.

You may qualify if:

• Female aged between 18 and 50 years
• Endometriosis confirmed laparoscopically or radiologically (via ultrasound or MRI)
• Receiving treatment with Relugolix CT according to clinical practice for at least one month
• Pain score ≥40 on the VAS scale
• Regular menstrual cycles, (i.e., not in a menopausal or perimenopausal state)
• Signed informed consent

You may not qualify if:

• \- Menopausal status (natural or surgical)

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Cristiano Rossitto

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cristiano Rossitto

CONTACT

+390630155701; cristiano.rossitto@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: February 27, 2026
• Study Start: February 25, 2026
• Primary Completion (Estimated): December 25, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02