RecruitingEndometriosisPelvic Pain
Estradiol-mediated Inflammation and Central Sensitization in the Pathophysiology of Endometriosis-associated Pelvic Pain
Eligible age
18–49 yrs
Accepts
Women
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
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About this study
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.
Sponsor: University of Michigan
You may qualify if…
- ✓ 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)
- ✓ Willing to undergo quantitative sensory testing (QST), fMRI and other study procedures
You may not qualify if…
- ✕ Contraindication to the use of relugolix CT (high risk of arterial or venous thrombotic, or thromboembolic disorder, known osteoporosis, current or history of breast cancer or other hormone sensitive malignancy, known hepatic impairment or disease, undiagnosed abnormal uterine bleeding, known hypersensitivity to components of relugolix CT).
- ✕ Concurrent participation in other therapeutic trials
- ✕ Pregnant, lactating, less than 6 months postpartum, or planning a pregnancy within next 12 months
- ✕ Planning pelvic or abdominal surgery during study period
- ✕ Prior major surgery in the past 4 months that involves incisions on the abdomen, chest, head, other than a skin biopsy (hysteroscopy, endometrial biopsy is ok to include).
- ✕ Planning to initiate a new adjunctive pain treatment during study treatment (e.g. cognitive behavioral therapy, physical therapy, acupuncture). Participants may be enrolled if these treatments are completed prior to trial or using stable therapies.
- ✕ History of hysterectomy and/or bilateral oophorectomy
- ✕ Clinically significant gynecologic condition such as significant endometrial pathology (e.g. endometrial hyperplasia), persistent ovarian cyst larger than 5 cm, largest uterine dimension \>15 centimeters and not planning an additional intervention or treatment for endometriosis, or another uterine or ovarian condition during the study period. Patients may be enrolled in this study if they were previously successfully treated for these conditions. Patients must have undergone pelvic ultrasound or MRI in the past 6 months, and provide results (or release of records to obtain results)
Where it's recruiting
Michigan
Ann Arbor
Source: ClinicalTrials.gov · NCT07100782 · last updated 2026-02-18