Estradiol-mediated Inflammation and Central Sensitization in the Pathophysiology of Endometriosis-associated Pelvic Pain

Exclusion Criteria

• •Contraindication to the use of relugolix CT (high risk of arterial or venous thrombotic, or thromboembolic disorder, known osteoporosis, current or history of breast cancer or other hormone sensitive malignancy, known hepatic impairment or disease, undiagnosed abnormal uterine bleeding, known hypersensitivity to components of relugolix CT).
• •Concurrent participation in other therapeutic trials
• •Pregnant, lactating, less than 6 months postpartum, or planning a pregnancy within next 12 months
• •Planning pelvic or abdominal surgery during study period
• •Prior major surgery in the past 4 months that involves incisions on the abdomen, chest, head, other than a skin biopsy (hysteroscopy, endometrial biopsy is ok to include).
• •Planning to initiate a new adjunctive pain treatment during study treatment (e.g. cognitive behavioral therapy, physical therapy, acupuncture). Participants may be enrolled if these treatments are completed prior to trial or using stable therapies.
• •History of hysterectomy and/or bilateral oophorectomy
• •Clinically significant gynecologic condition such as significant endometrial pathology (e.g. endometrial hyperplasia), persistent ovarian cyst larger than 5 cm, largest uterine dimension \>15 centimeters and not planning an additional intervention or treatment for endometriosis, or another uterine or ovarian condition during the study period. Patients may be enrolled in this study if they were previously successfully treated for these conditions. Patients must have undergone pelvic ultrasound or MRI in the past 6 months, and provide results (or release of records to obtain results)
• •History or current evidence of psychosis, current suicide risk or attempt within 2 years of study (note: participants with mood disorders such as depression or anxiety will not be excluded)
• •Chronic opioid, alcohol, and/or illicit drug use
• •History of substance abuse within past one year
• •Unable or unwilling to discontinue opioids analgesics within 48 hours of the dense phenotyping study visits
• •Medical conditions that may significantly interfere with relugolix CT efficacy, ability to fully comply or would make it unsafe for participants to take part in the study, including but not limited to: morbid obesity with Body Mass Index \> 45, uncontrolled autoimmune/inflammatory diseases, significant cardiopulmonary disease (e.g., angina, congestive heart failure, uncontrolled hypertension, severe cardiac valvular disease, Chronic Obstructive Pulmonary Disease (COPD), chronic asthma), renal or liver disease (e.g. cirrhosis, hepatitis), uncontrolled endocrine or allergic disorders (e.g., hypothyroidism, diabetes, allergic rhinitis), neurologic conditions (e.g., multiple sclerosis, prior stroke, neurological tumor), severe physical impairment (e.g., blindness, deafness, paraplegia); and active malignancy (any malignancy except for localized dermatologic cancer).
• •Any impairment, activity or situation that in the judgment of the Study Coordinator or Principal Investigator would prevent safe or satisfactory completion of the study protocol.
• •Individuals receiving or applying for compensation or disability and other aspects associated with potential secondary gain per self-report;
• •Additional exclusion that prevent participation in QST and fMRI:
• •1. Severe claustrophobia precluding MRI and evoked pain testing during scanning;
• •2. Diagnosed peripheral neuropathy
• •3. Diagnosed epilepsy
• •4. Diagnosed or self-reported visual-evoked migraines can participate in study, but will not participate in the visual testing procedures.
• •5. Weigh \>300 pounds