Estradiol-mediated Inflammation and Central Sensitization in the Pathophysiology of Endometriosis-associated Pelvic Pain
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-49
SponsorUniversity of Michigan
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Relugolix CT
Treatment groups
130 Participants
are divided into 1 treatment groupSponsors and collaborators
University of Michigan
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov