Relugolix for Endometriosis Associated Pain
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-50
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
None
Trial design
Treatments tested in this trial
- Patients with a diagnosis of endometriosis receiving treatment with Relugolix CT, according to clinical practice,
Treatment groups
No treatment groups listed
Locations
Sponsors and collaborators
Source ClinicalTrials.gov