Actively Recruiting

Phase 3
Age: 18Years - 49Years
FEMALE
NCT07100782

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

Led by University of Michigan · Updated on 2026-02-18

130

Participants Needed

1

Research Sites

142 weeks

Total Duration

On this page

Sponsors

U

University of Michigan

Lead Sponsor

E

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

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 49Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Premenopausal woman aged 18 to 49 years at consent
  • History of endometriosis diagnosed by surgery, ultrasound, or MRI within 10 years
  • Self-reported moderate to severe pelvic pain lasting 6 months or more
  • Willingness to participate in the relugolix CT drug trial
  • No injectable hormone therapy use in past 6 months
  • Willingness to complete 30-60 day washout of other hormonal therapies if applicable
  • Willingness to use two forms of non-hormonal contraception during the study or history of bilateral tubal occlusion at least 3 months prior
  • Willingness to undergo quantitative sensory testing (QST), fMRI, and other study procedures
  • Ability to read and speak English for consent and questionnaires
  • Normal or correctable vision to 20/40 for MRI and visual testing
  • No contraindications to MRI (e.g., metal implants, claustrophobia)
  • Willingness to refrain from certain pain medications 12 hours before neuroimaging and QST
  • Willingness to avoid alcohol and nicotine on day of QST and neuroimaging
  • Willingness to avoid exercise causing soreness for 48 hours before testing
  • Able to lie still on their back for 1 hour during MRI
  • Weighs 300 pounds or less
  • Completion of more than 60% of daily electronic diary entries during screening
  • At least two menstrual flows separated by 21 days during washout/screening
  • Confirmed moderate to severe non-menstrual pain and dysmenorrhea in diary during screening
Not Eligible

You will not qualify if you...

  • Contraindications to relugolix CT (e.g., high risk of thrombotic disorders, osteoporosis, hormone-sensitive cancers, hepatic impairment, abnormal uterine bleeding, hypersensitivity to relugolix CT components)
  • Participation in other therapeutic trials
  • Pregnant, lactating, less than 6 months postpartum, or planning pregnancy within 12 months
  • Planned pelvic or abdominal surgery during study
  • Major surgery within past 4 months involving abdomen, chest, or head (except skin biopsy, hysteroscopy, or endometrial biopsy)
  • Planning new adjunctive pain treatments during study period
  • History of hysterectomy or bilateral oophorectomy
  • Significant gynecologic conditions requiring intervention, unless previously treated
  • History or current psychosis, suicide risk, or attempt within 2 years
  • Chronic opioid, alcohol, or illicit drug use
  • Substance abuse in past year
  • Unable or unwilling to stop opioid analgesics 48 hours before phenotyping visits
  • Medical conditions interfering with treatment or study participation, including morbid obesity (BMI > 45), uncontrolled autoimmune/inflammatory diseases, serious cardiopulmonary, renal, liver, endocrine, neurologic conditions, severe physical impairments, or active malignancy except localized skin cancer
  • Any condition preventing safe or satisfactory study completion
  • Receiving or applying for compensation or disability with potential secondary gain
  • Additional exclusions for QST and fMRI: severe claustrophobia, peripheral neuropathy, epilepsy, visual-evoked migraines (excluded from visual testing), weight over 300 pounds

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Michigan

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

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Research Team

K

Kathy Scott

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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