AzTrials
AzTrials

EndometriosisPhase 3NCT07100782

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

A Phase 3 study testing Relugolix CT in people with Endometriosis and Pelvic Pain, run by University of Michigan at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 49 years, women only
Conditions the study is for
Endometriosis, Pelvic Pain
What is being tested?
Relugolix CT
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
1 siteUnited States
Study dates
8 Dec 2025to Sep 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 49 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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®).
  • Willingness to 30-60 day washout interval of oral, vaginal, transdermal, intrauterine hormonal therapies prior to study initiation if applicable
Show all 21Show fewer
  • Willingness to use 2 forms of non-hormonal contraception during the entire duration of the study period or has had a history of a bilateral tubal occlusion procedure at least 3 months prior to screening (tubal ligation or hysteroscopic occlusion method)
  • Willing to undergo quantitative sensory testing (QST), fMRI and other study procedures
  • Ability to read and speak English to allow for written informed consent, phenotyping, and patient-reported outcomes measures
  • Meet criteria to participate in QST and fMRI. These include:
  • Normal visual acuity or correctable (with corrective lenses- glasses or contacts) to at least 20/40 for reading instructions in the MRI and visual sensitivity testing
  • No contraindications to MRI (e.g., metal implants, claustrophobia)
  • Willingness to refrain from pain medications such as NSAIDs, acetaminophen, and opioids for 12 hours prior to neuroimaging and QST
  • Willingness to refrain from alcohol and nicotine on day of QST and neuroimaging (alcohol and nicotine consumption is allowed after testing is completed)
  • Willingness to refrain from physical activity or exercise that would cause muscle and/or joint soreness for 48 hours prior to testing (routine exercise or activity that does not lead to soreness is acceptable)
  • Able to lie still on their back for 1 hour during MRI
  • Weigh 300 pounds or less.
  • Additional inclusion criteria to proceed with Study Visit 2 and clinical trial:
  • >60% complete entries in daily electronic diary (end-of-day pain, bleeding, fatigue scores)
  • Minimum of two menstrual flows separated by a minimum of 21 days (d1 bleed to next d1 bleed) during the washout/screening period
  • Moderate-severe non-menstrual pain and dysmenorrhea confirmed with daily electronic diary in the washout/screening period.

Who cannot join

  • Contraindication to the use of relugolix CT (high risk of arterial or venous thrombotic, or thromboembolic disorder, known osteoporosis, current or history of breast cancer or other hormone sensitive malignancy, known hepatic impairment or disease, undiagnosed abnormal uterine bleeding, known hypersensitivity to components of relugolix CT).
  • Concurrent participation in other therapeutic trials
  • Pregnant, lactating, less than 6 months postpartum, or planning a pregnancy within next 12 months
  • Planning pelvic or abdominal surgery during study period
  • Prior major surgery in the past 4 months that involves incisions on the abdomen, chest, head, other than a skin biopsy (hysteroscopy, endometrial biopsy is ok to include).
  • Planning to initiate a new adjunctive pain treatment during study treatment (e.g. cognitive behavioral therapy, physical therapy, acupuncture). Participants may be enrolled if these treatments are completed prior to trial or using stable therapies.
Show all 21Show fewer
  • History of hysterectomy and/or bilateral oophorectomy
  • Clinically significant gynecologic condition such as significant endometrial pathology (e.g. endometrial hyperplasia), persistent ovarian cyst larger than 5 cm, largest uterine dimension >15 centimeters and not planning an additional intervention or treatment for endometriosis, or another uterine or ovarian condition during the study period. Patients may be enrolled in this study if they were previously successfully treated for these conditions. Patients must have undergone pelvic ultrasound or MRI in the past 6 months, and provide results (or release of records to obtain results)
  • History or current evidence of psychosis, current suicide risk or attempt within 2 years of study (note: participants with mood disorders such as depression or anxiety will not be excluded)
  • Chronic opioid, alcohol, and/or illicit drug use
  • History of substance abuse within past one year
  • Unable or unwilling to discontinue opioids analgesics within 48 hours of the dense phenotyping study visits
  • Medical conditions that may significantly interfere with relugolix CT efficacy, ability to fully comply or would make it unsafe for participants to take part in the study, including but not limited to: morbid obesity with Body Mass Index > 45, uncontrolled autoimmune/inflammatory diseases, significant cardiopulmonary disease (e.g., angina, congestive heart failure, uncontrolled hypertension, severe cardiac valvular disease, Chronic Obstructive Pulmonary Disease (COPD), chronic asthma), renal or liver disease (e.g. cirrhosis, hepatitis), uncontrolled endocrine or allergic disorders (e.g., hypothyroidism, diabetes, allergic rhinitis), neurologic conditions (e.g., multiple sclerosis, prior stroke, neurological tumor), severe physical impairment (e.g., blindness, deafness, paraplegia); and active malignancy (any malignancy except for localized dermatologic cancer).
  • Any impairment, activity or situation that in the judgment of the Study Coordinator or Principal Investigator would prevent safe or satisfactory completion of the study protocol.
  • Individuals receiving or applying for compensation or disability and other aspects associated with potential secondary gain per self-report;
  • Additional exclusion that prevent participation in QST and fMRI:
  • Severe claustrophobia precluding MRI and evoked pain testing during scanning;
  • Diagnosed peripheral neuropathy
  • Diagnosed epilepsy
  • Diagnosed or self-reported visual-evoked migraines can participate in study, but will not participate in the visual testing procedures.
  • Weigh >300 pounds

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Kathy Scott contact

734-998-7022

jrsj@med.umich.edu

United States1 site, 1 recruiting

  • University of Michigan

    Ann Arbor, Michigan, 48109

    Kathy Scott, 734-998-7022, jrsj@med.umich.edu

    Sawsan As-Sanie, MD, MPH

    Recruiting

Other trials in United States

About this study

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.

Read the 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.

Being tested
Relugolix CT
Keywords
Relugolix Combination Therapy, Endo-EPIC (Alternative study acronym/title)
Medical subject headings
Endometriosis, Pelvic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Relugolix CTDrug

    Also called Myfembree

    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 groups in NCT07100782
Study groupRoleWhat they receive
Relugolix CTExperimentalAll 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.
Receives: Drug: Relugolix CT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change score in lipopolysaccharide (LPS)-stimulated Macrophage inflammatory protein-1 alpha (MIP1-α) levels

    LPS-stimulated MIP1-α levels measured from whole blood

    Measured: baseline and week 12 visit

  2. Change score for functional magnetic resonance imaging (fMRI) connectivity of the somatosensory cortices to the default-mode network

    Assessed using a functional connectivity MRI (fcMRI) at rest and applied pain

    Measured: baseline and week 12 visit

Secondary outcomes (2)

  1. Change scores for pelvic pain interference

    Pain interference assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) 29+2 Profile v2.1 pain interference domain. Each domain ranges in score from 4-20 and the higher the score indicates greater pain interference in the past 7 days.

    Measured: baseline and week 12 visit

  2. Change score for temporal summation at the forearm

    Temporal summation is calculated as the mean difference in pain ratings evoked by the single stimuli and the trains of stimuli using a 0-100 NRS.

    Measured: baseline and week 12 visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2025
  2. Study start8 Dec 2025
  3. Primary completionAug 2028 (estimated)
  4. Study completionSep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
All investigators will be blinded to wide-spread pain (WSP) status until final analysis.
Masking
None (open label)
Enrolment
130 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07100782
Sponsor's protocol ID
HUM00229564
Other IDs
R01HD108253
Status last verified
Feb 2026
First submitted
27 Jul 2025
Last updated
18 Feb 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified datasets including participant self-report data will be uploaded into a NIH compliant data repository (NIMH Data Archive and National Institute of Child Health and Human Development (NICHD) DASH)

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Relugolix CT in people with Endometriosis and Pelvic Pain, run by University of Michigan at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kathy Scott (734-998-7022, jrsj@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change score in lipopolysaccharide (LPS)-stimulated Macrophage inflammatory protein-1 alpha (MIP1-α) levels (time frame: baseline and week 12 visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07100782.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in