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

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan
Study ID
NCT07100782
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 49 Years
Healthy Volunteers
Not accepted

Interventions

  • Relugolix CT — DRUG
    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).

Study Details

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.

Key Dates

Start date
Dec 8, 2025
Status verified
Feb 2026
Primary completion
Aug 31, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
130 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Relugolix CT
    All participants will have the same intervention, but approximately half of those enrolled will have widespread pain and half will not. Approximately 65 participants with widespread pain will receive relugolix CT (relugolix 40mg, estradiol 1 mg, norethindrone acetate 0.5 mg once daily) daily for 24 weeks, and 65 participants without widespread pain will receive relugolix CT for 24 weeks.

Primary Outcome Measure

Change score in lipopolysaccharide (LPS)-stimulated Macrophage inflammatory protein-1 alpha (MIP1-α) levels [ Time Frame: baseline and week 12 visit ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48109
Kathy Scott
[email protected]
734-998-7022
Sawsan As-Sanie, MD, MPH (PRINCIPAL_INVESTIGATOR)

Find similar trials in Ann Arbor, MI

By condition
Endometriosis
By specialty
Women's healthFertility
By research site
University of Michigan· Ann Arbor, MI

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