Relugolix for Endometriosis Associated Pain

Starting soon

Conditions studied: Endometriosis, Endometriosis-related Pain, Pelvic Pain Syndrome

In brief

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.

Key facts

Study ID

NCT07440043

Run by

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

People needed

33

Starts

2026-02-25

Expected to finish

2027-02-28

Last updated by the study team

2026-02-27

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

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)

Full record on ClinicalTrials.gov

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