NCT07100782 Estradiol-mediated Inflammation and Central Sensitization in the Pathophysiology of Endometriosis-associated Pelvic Pain
| NCT ID | NCT07100782 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University of Michigan |
| Condition | Endometriosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 130 participants |
| Start Date | 2025-12-08 |
| Primary Completion | 2028-08 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
The purpose of this study is to better understand how hormone suppression with Relugolix Combination-Therapy (CT) affects pelvic pain, inflammation, and pain sensitivity in women with moderate-to-severe endometriosis associated pelvic pain.
Eligibility Criteria
Inclusion Criteria: * Premenopausal woman between age 18 and 49 years (inclusive) at the time of consent. Menopause is defined as amenorrhea \>1 year unrelated to hormonal suppression. * History of endometriosis diagnosed by surgery (visual or biopsy confirmed), ultrasound, or MRI within 10 years of study entry * History of self-reported moderate to severe pelvic pain for ≥ 6 months' duration at time of screening visit. * Willingness to participate in a relugolix CT drug intervention trial * Has not used an injectable hormone therapy in the past 6 months (e.g. DepoProvera®, DepoLupron®). * Willingness to 30-60 day washout interval of oral, vaginal, transdermal, intrauterine hormonal therapies prior to study initiation if applicable * Willingness to use 2 forms of non-hormonal contraception during the entire duration of the study period or has had a history of a bilateral tubal occlusion procedure at least 3 months prior to screening (tubal ligation or hysteroscopic occlusion method) *