Clinical trial NCT06279195: Phenotyping of Idiopathic Pelvic Pain With Real-time Uterine Imaging and Relugolix-Combination Therapy Treatment
Official title: Comprehensive Mechanistic Phenotyping of Idiopathic Pelvic Pain With Real-time Uterine Imaging and Relugolix-Combination Therapy Treatment
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Pelvic Pain
Keywords: Idiopathic Pelvic Pain
Pelvic Pain
Lead sponsor: Endeavor Health
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2024-02-26
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants in two groups with different conditions will be give REL-CT.
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Correlation between post-treatment pelvic pain and baseline uterine contraction frequency
timeFrame: 6 months
measure: Correlation between post-treatment pelvic pain and baseline sensory hypersensitivity Z-score.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Evanston
country: United States
facility: NorthShore University HealthSystem
state: Illinois
Study officials:
References:
citation: 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.
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.