NCT06279195

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

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Endeavor Health · Academic / Other
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DRUG	Relugolix (40 mg) /estradiol (1 mg)/norethisterone acetate (0.5 mg) oral tablet	All participants will be instructed to take REL-CT.

Timeline

• Start date: 2024-06-01
• Primary completion: 2025-11-02
• Completion: 2025-11-02
• First posted: 2024-02-26
• Last updated: 2025-08-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study