NCT07100782

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: University of Michigan · Academic / Other
• Sex: Female
• Age: 18 Years – 49 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Endometriosis
• Pelvic Pain

Interventions

Type	Name	Description
DRUG	Relugolix 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).

Timeline

• Start date: 2025-12-08
• Primary completion: 2028-08-01
• Completion: 2028-09-01
• First posted: 2025-08-03
• Last updated: 2026-02-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study