Phenotyping of Idiopathic Pelvic Pain With Real-time Uterine Imaging and Relugolix-Combination Therapy Treatment

August 21, 2025 updated by: Kevin Hellman, Endeavor Health

Comprehensive Mechanistic Phenotyping of Idiopathic Pelvic Pain With Real-time Uterine Imaging and Relugolix-Combination Therapy Treatment

The mechanisms underlying variable efficacy of Relugolix-Combination Therapy (REL-CT) in mitigating unexplained pelvic pain will be evaluated with uterine imaging techniques and quantitative sensory testing.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

The mechanisms underlying variable efficacy of Relugolix-Combination Therapy (REL-CT) in mitigating unexplained pelvic pain will be evaluated with real-time uterine imaging techniques and quantitative sensory testing. Advanced MRI methodology enables the assessment of various uterine parameters, including contractions, peristalsis, perfusion, blood oxygenation, and structural factors. Importantly, it is possible to temporally correlate these mechanisms with self-reported spontaneous menstrual cramping pain through real-time imaging.

In the first aim of this proposal (Aim #1), mechanisms underlying unexplained menstrual pain phenotypes linked to deficiencies in myometrial activity, perfusion, and oxygenation and evaluate the subsequent impact of REL-CT will be evaluated. Aim #2 focuses on characterizing unexplained menstrual pain phenotypes associated with impairments in the central nervous system sensory functions and the effects of REL-CT. Quantitative sensory testing methods will be used to comprehensively assesses peripheral, central ascending, central integrating, and central descending nervous system components related to pelvic pain. In the past, this testing can identify central nervous system component pain that predicts the pain trajectory and corresponds with treatment outcomes.

By analyzing the relationship between the variable effectiveness of REL-CT treatment to observed mechanisms in menstrual pain, it may possible to identify specific unexplained pelvic pain phenotypes amenable to medical management. Furthermore, because that the precise mechanisms by which REL-CT alleviates menstrual pain in endometriosis remain incompletely understood, a cohort of endometriosis patients will be also studied. The overarching objective is to uncover the underlying mechanisms that advance the comprehension of menstrual pain biology and establish these mechanisms as phenotypic markers for treating REL-CT.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Evanston, Illinois, United States, 60201
        • NorthShore University Healthsystem

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

Idiopathic pelvic pain (40 participants):

  • Self-report an average non-menstrual pelvic pain rating of ≥ 2/10 (on a 0 to 10 Numeric Rating Scale) over the past 6 months.
  • Not have received a prior diagnosis attributed to a secondary cause (e.g., leiomyoma, endometriosis).

Endometriosis (20 participants)

  • Self-report an average non-menstrual pelvic pain rating of ≥ 2/10 (on a 0 to 10 Numeric Rating Scale) over the past
  • Previously confirmed surgical diagnosis of stage III-IV endometriosis, indicating potential remission.

Exclusion Criteria:

  • History of blood clots,
  • Allergies to REL-CT ingredients
  • Diabetes
  • Migraines
  • Osteoporosis
  • Vascular disease
  • Hormone-sensitive cancers
  • Smoking.
  • Missing limbs
  • Paralysis,
  • Conditions associated with irregular menses
  • Congenital conditions affecting reproductive function
  • Intrauterine device use
  • Pelvic inflammatory conditions
  • Active genitourinary infections,
  • Inability to read or comprehend the informed consent document written in English
  • History of metallic implants, history of metallic injury, any condition precluding investigation with MRI
  • BMI exceeding 40
  • Uncontrolled thyroid dysfunction
  • Adrenal dysfunction
  • Renal disorders
  • Liver disorders
  • Coagulopathy,
  • Gastrointestinal conditions or surgeries that may affect absorption

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Idiopathic Pelvic Pain
Participants with Idiopathic Pelvic Pain must: 1. Self-report an average non-menstrual pelvic pain rating of ≥ 4/10 (on a 0 to 10 Numeric Rating Scale) over the past 6 months. 2. Not have received a prior diagnosis attributed to a secondary cause (e.g., leiomyoma, endometriosis). Participants will be instructed to start taking Relugolix-combination therapy (40 mg of relugolix, 1 mg of estradiol, and 0.5 mg of norethindrone acetate) within 7 days of their period starting, at the same time every day for the next 6 months.
Drug: Relugolix (40 mg) /estradiol (1 mg)/norethisterone acetate (0.5 mg) oral tablet
All participants will be instructed to take REL-CT.
Other Names:
  • Myfembree
  • Relugolix Combination Therapy
  • REL-CT
Experimental: Endometriosis:
Participants with Endometriosis: 1. Must self-report an average non-menstrual pelvic pain rating of ≥ 4/10 (on a 0 to 10 Numeric Rating Scale) over the past 6 months. 2. Have a previously confirmed surgical diagnosis of stage III-IV endometriosis, indicating potential remission. Participants will be instructed to start taking Relugolix-combination therapy (40 mg of relugolix, 1 mg of estradiol, and 0.5 mg of norethindrone acetate) within 7 days of their period starting, at the same time every day for the next 6 months.
Drug: Relugolix (40 mg) /estradiol (1 mg)/norethisterone acetate (0.5 mg) oral tablet
All participants will be instructed to take REL-CT.
Other Names:
  • Myfembree
  • Relugolix Combination Therapy
  • REL-CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between post-treatment pelvic pain and baseline uterine contraction frequency
Time Frame: 6 months
At baseline before intervention, the number of contractions over a 10 minute period will be measured with MRI.Participants will complete a pain diaries before REL-CT treatment and 6 months after starting REL-CT treatment. Participants will be asked to rate their overall pelvic, bladder test pain and bowel pain at the end of the day via REDCap (on 0-10 scale, 0 no pain, 10 worst pain imaginable). The average pain ratings during non-menstrual days will be used to generate continuous ratings of pelvic pain for each diary. The correlation coefficient between the amount of contractions measured with MRI and average non-menstrual pelvic pain will be calculated.
6 months
Correlation between post-treatment pelvic pain and baseline sensory hypersensitivity Z-score.
Time Frame: 6 months
A composite Z-scored total sensory hypersensitivity score will be calculated by summing the z-scores obtained from the baseline sensory tests during bladder pain, bodily pressure pain threshold, and visual/audio tests at baseline. The correlation coefficient between the Z-scored total sensory hypersensitivity scored and average non-menstrual pelvic pain will be calculated.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Endeavor Health

Collaborators

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

November 2, 2025

Study Completion (Estimated)

November 2, 2025

Study Registration Dates

First Submitted

February 13, 2024

First Submitted That Met QC Criteria

February 20, 2024

First Posted (Actual)

February 26, 2024

Study Record Updates

Last Update Posted (Estimated)

August 28, 2025

Last Update Submitted That Met QC Criteria

August 21, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EH23-326

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We plan to share anonymized data with potentially interested experience scientific researchers. Shared data includes pain diary, questionnaire data, MRI data, and sensory testing data.

IPD Sharing Time Frame

18 months.

IPD Sharing Access Criteria

Data obtained through this study may be provided to qualified researchers with academic interest in pelvic pain. Data or samples shared will be coded, with no personally identifying included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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