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
This trial does not accept healthy volunteersQualifiers
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 population
Patients with a diagnosis of endometriosis who have been receiving treatment with Relugolix CT according to clinical practice for at least one month.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Patients with a diagnosis of endometriosis receiving treatment with Relugolix CT, according to clinical practice,
Other interventionCollection of clinical, demographic, laboratory, instrumental, and treatment data. Data will be collected from the patients' medical records.
Treatment groups
No treatment groups listed
Trial outcomes
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.
Time frame
24 weeksSecondary outcomes
1
Evaluation of reduction in other endometriosis-associated symptoms
Change from baseline in dyspareunia, dyschezia, and dysuria after a 24-week treatment period with Relugolix CT.
Time frame
24 weeks2
Evaluation of reduction in VAS score
The proportion of participants achieving ≥30% and ≥50% reduction in VAS pain score after 24 weeks of treatment compared with baseline.
Time frame
24 weeks3
Changes in ultrasound findings.
Changes in findings from transvaginal ultrasound examinations.
Time frame
24 weeks4
Evaluation of patient satisfaction
Patient satisfaction with treatment, assessed using a five-category scale (very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied, very dissatisfied) administered at the end of the 24-week period.
Time frame
24 weeksLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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