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

NCT07100782 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2026-02-18

No results posted yet for this study

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.

Conditions

  • Endometriosis
  • Pelvic Pain

Interventions

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).

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • University of Michigan

    lead OTHER

Principal Investigators

  • Sawsan As-Sanie, MD, MPH · University of Michigan

  • Andrew Schrepf, PhD · University of Michigan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-08
Primary Completion
2028-08-31
Completion
2028-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07100782 on ClinicalTrials.gov