Phenotyping of Idiopathic Pelvic Pain With Real-time Uterine Imaging &

Status Not yet recruiting

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Pelvic Pain

Clinical Trial Details

NCT number	NCT06279195
Study type	Interventional
Source	NorthShore University HealthSystem
Contact	Kevin Hellman, PhD
Phone	847-570-2644
Email	khellman@northshore.org
Status	Not yet recruiting
Phase	Phase 2
Start date	April 5, 2024
Completion date	August 2, 2025

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04077801` - Effect Of Chronic Pelvic Pain on Lumbopelvic Alignment And TemproMandibular Joint Kinematics in Women
Completed	`NCT03740932` - Effect of Biomechanical Alignment and Jaw on Women With Pelvic Pain
Completed	`NCT04081532` - The Effectiveness of Laparoscopic Treatment of Superficial Endometriosis for Managing Chronic Pelvic Pain	N/A
Recruiting	`NCT06101303` - Endometriosis Pain
Recruiting	`NCT03868137` - Multi-dose Ibuprofen Prophylaxis for IUD-insertion	N/A
Suspended	`NCT04069572` - Vibratory Stimulation for the Treatment of Chronic Pain	N/A
Completed	`NCT02923245` - POCUS Assessment of Bladder Fullness for Girls Awaiting Radiology-Performed Transabdominal Pelvic Ultrasound	N/A
Completed	`NCT02547857` - Transvaginal Pelvic Ultrasound in the ED	N/A
Completed	`NCT01938092` - Vaginal Diazepam for the Treatment of Female Pelvic Pain	Phase 2
Active, not recruiting	`NCT01731470` - Intravesical Liposomes for Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS)	N/A
Completed	`NCT01421641` - Tenaculum Pain Control Study	Phase 4
Completed	`NCT00034047` - Endometriosis : Traditional Medicine vs Hormone Therapy	Phase 1/Phase 2
Completed	`NCT05368155` - Chronic Pelvic Pain and Education Skills Training for Women Veterans	N/A
Completed	`NCT04179149` - Enriched Environments in Endometriosis	N/A
Not yet recruiting	`NCT05530681` - Correlation Pelvic Floor Function and Ultrasound Findings One Year After Childbirth	N/A
Completed	`NCT04077775` - Temporomandibular Joint Kinematics Changes in Pregnant Women: A Case-control Study
Completed	`NCT03715777` - Electromyographic Study for the Help and Guidance of BoNTA Administration in the Treatment of Chronic Pelvic Floor Pain	Phase 3
Recruiting	`NCT05926752` - Photobiomodulation for Myofascial Pelvic Pain	N/A
Completed	`NCT02588885` - Restoring Emotional, Sexual, and Physical Empowerment Through CBT & Trauma-sensitive Care: A Chronic Pelvic Pain Intervention	N/A
Completed	`NCT02261740` - Program to Overcome Pelvic Pain With Yoga	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms