Estradiol-mediated Inflammation and Central Sensitization in the Pathophysiology of Endometriosis-associated Pelvic Pain
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-49
SponsorUniversity of Michigan
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Premenopausal woman between age 18 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 10 years of study entry
History of self-reported moderate to severe pelvic pain for ≥ 6 months' duration at time of screening visit.
Willingness to participate in a relugolix CT drug intervention trial
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Relugolix CT
DrugStudy medication will be provided by Sumitomo in pill bottles containing an 84-day supply of relugolix 40mg, estradiol 1mg, norethindrone acetate 0.5mg (Relugolix Combination therapy).
Treatment groups
130 Participants
are divided into 1 treatment groupGroup A: Relugolix CTExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change score in lipopolysaccharide (LPS)-stimulated Macrophage inflammatory protein-1 alpha (MIP1-α) levels
LPS-stimulated MIP1-α levels measured from whole blood
Time frame
baseline and week 12 visit2
Change score for functional magnetic resonance imaging (fMRI) connectivity of the somatosensory cortices to the default-mode network
Assessed using a functional connectivity MRI (fcMRI) at rest and applied pain
Time frame
baseline and week 12 visitSecondary outcomes
1
Change scores for pelvic pain interference
Pain interference assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) 29+2 Profile v2.1 pain interference domain. Each domain ranges in score from 4-20 and the higher the score indicates greater pain interference in the past 7 days.
Time frame
baseline and week 12 visit2
Change score for temporal summation at the forearm
Temporal summation is calculated as the mean difference in pain ratings evoked by the single stimuli and the trains of stimuli using a 0-100 NRS.
Time frame
baseline and week 12 visitSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Michigan
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov