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.
Endometriosis is a chronic, estrogen-dependent condition frequently associated with pelvic pain and impaired quality of life. Despite available hormonal treatments, unmet clinical needs remain in terms of long-term efficacy and tolerability. Relugolix combination therapy (CT), an oral GnRH receptor antagonist combined with estradiol and norethisterone acetate, has shown efficacy in randomized trials, but real-world data are limited. The RELAX study is a single-center, ambispective observational study evaluating the effectiveness of relugolix CT in routine clinical practice. Women aged 18-50 years with laparoscopically or radiologically confirmed endometriosis receiving relugolix CT will be included. Both retrospective and prospective data will be collected. The primary objective is to assess the change from baseline in chronic pelvic pain measured by the Visual Analog Scale (VAS) after 24 weeks of treatment. Secondary outcomes include changes in dyspareunia, dyschezia, and dysuria; the proportion of patients achieving ≥30% and ≥50% reduction in VAS pain score; changes in transvaginal ultrasound findings; patient satisfaction; and safety. This study aims to provide real-world evidence to support clinical decision-making in the management of endometriosis-associated pain.
Study Type
OBSERVATIONAL
Enrollment
33
Collection of clinical, demographic, laboratory, instrumental, and treatment data. Data will be collected from the patients' medical records.
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 weeks
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 weeks
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 weeks
Changes in ultrasound findings.
Changes in findings from transvaginal ultrasound examinations.
Time frame: 24 weeks
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 weeks
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