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

NCT06279195 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: EH23-326
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pelvic Pain

Keywords

Idiopathic Pelvic Pain; Pelvic Pain

Outcome Measures

Primary Outcomes (2)

• Correlation between post-treatment pelvic pain and baseline uterine contraction frequency

  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.

  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

Study Arms (2)

Idiopathic Pelvic Pain

EXPERIMENTAL

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

Endometriosis:

EXPERIMENTAL

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

Interventions

Relugolix (40 mg) /estradiol (1 mg)/norethisterone acetate (0.5 mg) oral tablet DRUG

All participants will be instructed to take REL-CT.

Also known as: Myfembree, Relugolix Combination Therapy, REL-CT

Endometriosis:; Idiopathic Pelvic Pain

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Endeavor Health: lead
• Pfizer: collaborator

Study Sites (1)

NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

Location

Related Publications (2)

• Hellman KM, Kuhn CS, Tu FF, Dillane KE, Shlobin NA, Senapati S, Zhou X, Li W, Prasad PV. Cine MRI during spontaneous cramps in women with menstrual pain. Am J Obstet Gynecol. 2018 May;218(5):506.e1-506.e8. doi: 10.1016/j.ajog.2018.01.035. Epub 2018 Feb 2.

  PMID: 29409786 BACKGROUND

• Kmiecik MJ, Tu FF, Silton RL, Dillane KE, Roth GE, Harte SE, Hellman KM. Cortical mechanisms of visual hypersensitivity in women at risk for chronic pelvic pain. Pain. 2022 Jun 1;163(6):1035-1048. doi: 10.1097/j.pain.0000000000002469. Epub 2021 Aug 27.

  PMID: 34510138 BACKGROUND

MeSH Terms

Conditions

Pelvic Pain

Interventions

relugolix; Estradiol; Norethindrone Acetate; Tablets

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Norethindrone; Norpregnenes; Norpregnanes; Norsteroids; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate Professor

Model Details: Participants in two groups with different conditions will be give REL-CT.

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: February 26, 2024
• Study Start: June 1, 2024
• Primary Completion: November 2, 2025
• Study Completion: November 2, 2025
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 18 months.
• 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.

Locations

US (1)