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

WithdrawnPhase 2

Sponsor: Endeavor Health

Conditions: Pelvic Pain

Interventions: Relugolix (40 mg) /estradiol (1 mg)/norethisterone acetate (0.5 mg) oral tablet

Countries: United States

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.

Eligibility overview

Sex: FEMALE

Age: 18 Years to 35 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (1)

Evanston, Illinois, United States