AzTrials
AzTrials

Pelvic PainPhase 2NCT06279195

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

A Phase 2 study testing Relugolix (40 mg) /estradiol (1 mg)/norethisterone acetate (0.5 mg) oral tablet in people with Pelvic Pain, run by Endeavor Health at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 35 years, women only
Conditions the study is for
Pelvic Pain
What is being tested?
Relugolix (40 mg) /estradiol (1 mg)/norethisterone acetate (0.5 mg) oral tablet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
1 Jun 2024to 2 Nov 2025
Phase
Phase 2
Are there results?
None posted in the registry

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 35 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • History of blood clots,
  • Allergies to REL-CT ingredients
  • Diabetes
  • Migraines
  • Osteoporosis
  • Vascular disease
Show all 24Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • NorthShore University HealthSystem

    Evanston, Illinois, 60201

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Pelvic Pain
Being tested
Relugolix (40 mg) /estradiol (1 mg)/norethisterone acetate (0.5 mg) oral tablet
Keywords
Idiopathic Pelvic Pain, Pelvic Pain
Medical subject headings
Pelvic Pain

What participants receive

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

  • Relugolix (40 mg) /estradiol (1 mg)/norethisterone acetate (0.5 mg) oral tabletDrug

    Also called Myfembree, Relugolix Combination Therapy, REL-CT

    All participants will be instructed to take REL-CT.

Study groups in NCT06279195
Study groupRoleWhat they receive
Idiopathic Pelvic PainExperimentalParticipants 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.
Receives: Drug: Relugolix (40 mg) /estradiol (1 mg)/norethisterone acetate (0.5 mg) oral tablet
Endometriosis:ExperimentalParticipants 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.
Receives: Drug: Relugolix (40 mg) /estradiol (1 mg)/norethisterone acetate (0.5 mg) oral tablet

What is being measured

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

  1. 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.

    Measured: 6 months

  2. 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.

    Measured: 6 months

Timeline

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

  1. First posted26 Feb 2024
  2. Study start1 Jun 2024 (estimated)
  3. Primary completion2 Nov 2025 (estimated)
  4. Study completion2 Nov 2025 (estimated)

Why it stopped: Could not obtain approval for the planned study with available funding

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 2
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Participants in two groups with different conditions will be give REL-CT.
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06279195
Sponsor's protocol ID
EH23-326
Status last verified
Aug 2025
First submitted
13 Feb 2024
Last updated
28 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 29409786

  • 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.

    PubMed 34510138

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Relugolix (40 mg) /estradiol (1 mg)/norethisterone acetate (0.5 mg) oral tablet in people with Pelvic Pain, run by Endeavor Health 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 6 inclusion and 24 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: withdrawn, as of the sponsor's last update on 28 Aug 2025. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Correlation between post-treatment pelvic pain and baseline uterine contraction frequency (time frame: 6 months). 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 NCT06279195, which also lists 2 linked publications.

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 28 Aug 2025.

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