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Estradiol-mediated Inflammation and Central Sensitization in the Pathophysiology of Endometriosis-associated Pelvic Pain

StatusRecruiting
PhasePhase 3
Started2025-12-08
View on ClinicalTrials.gov ↗

Amendment history

2026-02-13
minor
Study Status, Oversight, Study Description, Eligibility v3
Start dateestimated 2025-11→confirmed 2025-12-08
Eligibility criteria+285 characters
Inclusion Criteria: Premenopausal woman between age 2118 and 49 years (inclusive) at the time of consent. Menopause [...] ery (visual or biopsy confirmed), ultrasound, or MRI within 510 years of study entry History of self-reported moderate to s [...] c pain for ≥ 6 months' duration at time of screening visit. Moderate-to-severe pelvic pain will be defined as self-report recall of average non-menstrual pelvic pain score over past 6 months as ≥ 4 on a 0-10 numeric rating scale (NRS) Willingness to participate in a relugolix CT drug intervention trial No use of adjunctive pain medications or on stable chroni [...] [...]
Study description+36 characters
[...] n Arbor, MI and Henry Ford, Detroit, MI and via social media and regional patient support groups). Endometrial biopsies will be sent via overnight courier t [...]
2025-09-12
minor
Study Status v2
Start date2025-08→2025-11
2025-08-12
notable
Not Yet Recruiting→Recruiting Study Status, Oversight, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Study sitesdetails revised at 1 of 1 site
2025-07-27
minor
Original filing
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.
Trial Details
NCT Number NCT07100782
Lead Sponsor University of Michigan
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions Endometriosis, Pelvic Pain
Enrollment 130 participants
Start Date 2025-12-08
Primary Completion 2028-08 (estimated)
Study Completion 2028-09 (estimated)
Updated on ClinicalTrials.gov 2026-02-18