Estradiol-mediated Inflammation and Central Sensitization in the Pathophysiology of Endometriosis-associated Pelvic Pain
University of Michigan
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.
Description
All clinical activities will be performed at University of Michigan (note that recruitment may occur at locations outside of University of Michigan, such as Trinity Health, Ann Arbor, MI and Henry Ford, Detroit, MI and via social media and regional patient support groups). Endometrial biopsies will be sent via overnight courier to Dr. Jie Yu's laboratory at The University of Buffalo for analysis.
Eligibility
- Age range
- 18–49 years
- Sex
- Female
- Healthy volunteers
- No
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®). * Wi…
Interventions
- DrugRelugolix CT
Study medication will be provided by Sumitomo in pill bottles containing an 84-day supply of relugolix 40mg, estradiol 1mg, norethindrone acetate 0.5mg (Relugolix Combination therapy).
Location
- University of MichiganAnn Arbor, Michigan