Estradiol-mediated Inflammation and Central Sensitization in the Pathophysiology of Endometriosis-associated Pelvic Pain
The purpose of this study is to better understand how hormone suppression with Relugolix Combination-Therapy (CT) affects pelvic pain, inflammation, and pain sensitivity in women with moderate-to-severe endometriosis associated pelvic pain.
• Premenopausal woman between age 21 and 49 years (inclusive) at the time of consent. Menopause is defined as amenorrhea \>1 year unrelated to hormonal suppression.
• History of endometriosis diagnosed by surgery (visual or biopsy confirmed), ultrasound, or MRI within 5 years of study entry
• History of self-reported moderate to severe pelvic pain for ≥ 6 months' duration at time of screening visit. Moderate-to-severe pelvic pain will be defined as self-report recall of average non-menstrual pelvic pain score over past 6 months as ≥ 4 on a 0-10 numeric rating scale (NRS)
• Willingness to participate in a relugolix CT drug intervention trial
• No use of adjunctive pain medications or on stable chronic daily use of adjunctive pain medications (excluding opioids);
• Has not used an injectable hormone therapy in the past 6 months (e.g. DepoProvera®, DepoLupron®).
• Willingness to 30-60 day washout interval of oral, vaginal, transdermal, intrauterine hormonal therapies prior to study initiation if applicable
• Willingness to use 2 forms of non-hormonal contraception during the entire duration of the study period or has had a history of a bilateral tubal occlusion procedure at least 3 months prior to screening (tubal ligation or hysteroscopic occlusion method)
• Willing to undergo quantitative sensory testing (QST), fMRI and other study procedures
• Ability to read and speak English to allow for written informed consent, phenotyping, and patient-reported outcomes measures
• Meet criteria to participate in QST and fMRI. These include:
• Normal visual acuity or correctable (with corrective lenses- glasses or contacts) to at least 20/40 for reading instructions in the MRI and visual sensitivity testing
• No contraindications to MRI (e.g., metal implants, claustrophobia)
• Willingness to refrain from pain medications such as NSAIDs, acetaminophen, and opioids for 12 hours prior to neuroimaging and QST
• Willingness to refrain from alcohol and nicotine on day of QST and neuroimaging (alcohol and nicotine consumption is allowed after testing is completed)
• Willingness to refrain from physical activity or exercise that would cause muscle and/or joint soreness for 48 hours prior to testing (routine exercise or activity that does not lead to soreness is acceptable)
• Able to lie still on their back for 1 hour during MRI