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

Pelvic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06279195
• Other study ID #: EH23-326
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: April 5, 2024
• Est. completion date: August 2, 2025

Study information

• Verified date: February 2024
• Source: NorthShore University HealthSystem
• Contact: Kevin Hellman, PhD
• Phone: 847-570-2644
• Email: khellman[@]northshore.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: August 2, 2025
• Est. primary completion date: August 2, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Pain

Intervention

Drug:
• Relugolix (40 mg) /estradiol (1 mg)/norethisterone acetate (0.5 mg) oral tablet
All participants will be instructed to take REL-CT.

Locations

Country	Name	City	State
United States	NorthShore University HealthSystem	Evanston	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
NorthShore University HealthSystem	Pfizer

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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