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New treatment option for Endometriosis
Official title Estradiol-mediated Inflammation and Central Sensitization in the Pathophysiology of Endometriosis-associated Pelvic Pain
ClinicalTrials.gov ID: NCT07100782
What this study is testing
What is Relugolix CT?
Relugolix CT is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for endometriosis.
Also referred to as Myfembree.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 49, women only
You may be able to join if
- Premenopausal woman between age 18 and 49 years (inclusive) at the time of consent. Menopause is defined as amenorrhea \>1 year unrelated to hormonal...
- 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
- Has not used an injectable hormone therapy in the past 6 months (e.g. DepoProvera®, DepoLupron®).
You likely can't join if
- Contraindication to the use of relugolix CT (high risk of arterial or venous thrombotic, or thromboembolic disorder, known osteoporosis, current or...
- 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...
- Planning to initiate a new adjunctive pain treatment during study treatment (e.g. cognitive behavioral therapy, physical therapy, acupuncture)...
See the full eligibility criteria
- 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
- 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...
- 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
- Weigh 300 pounds or less. Additional to proceed with Study Visit 2 and clinical trial:
- \>60% complete entries in daily electronic diary (end-of-day pain, bleeding, fatigue scores)
- Minimum of two menstrual flows separated by a minimum of 21 days (d1 bleed to next d1 bleed) during the washout/screening period
- Moderate-severe non-menstrual pain and dysmenorrhea confirmed with daily electronic diary in the washout/screening period.
- 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...
- 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...
- 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...
- 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 how well it works, ability to fully comply or would make it unsafe for participants to take part in the study, including but not limited to: morbid...
- 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:
- Severe claustrophobia precluding MRI and evoked pain testing during scanning;
- Diagnosed peripheral neuropathy
- Diagnosed epilepsy
- Diagnosed or self-reported visual-evoked migraines can participate in study, but will not participate in the visual testing procedures.
- Weigh \>300 pounds
The study team makes the final eligibility decision.
Where it's taking place
- Ann Arbor, Michigan, United States
Compensation & support
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 49 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ann Arbor, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.