Phase 3 Endometriosis Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Women who have not yet reached menopause, are between 18 and 49 years old at the time of signing consent, and have not had a period stop for more than one year for reasons unrelated to hormone treatment
• People with a history of endometriosis that was diagnosed through surgery (by sight or tissue sample), ultrasound, or MRI within the last 10 years before joining the study
• People who have experienced moderate to severe pelvic pain for at least 6 months at the time of their screening visit, based on their own report
• People who are willing to take part in a clinical trial involving a drug called relugolix combination therapy (relugolix CT)
• People who have not used an injectable hormone therapy (such as Depo-Provera or Depo-Lupron) in the past 6 months
• People who are willing to stop using oral, vaginal, skin patch, or intrauterine hormonal therapies for 30 to 60 days before the study begins, if applicable
• People who are willing to use two forms of non-hormonal contraception throughout the entire study, or who have had a permanent tubal blocking procedure (such as tubal ligation) at least 3 months before screening
• People who are willing to take part in specialised pain sensitivity testing (called quantitative sensory testing or QST) and brain scans (fMRI)
• People who are able to read and speak English well enough to give written consent and complete questionnaires
• People with normal vision, or vision that can be corrected to at least 20/40 with glasses or contact lenses, for reading instructions during the MRI and visual testing
• People who have no reasons they cannot safely have an MRI (such as metal implants or severe claustrophobia)
• People who are willing to avoid pain medicines such as anti-inflammatories (NSAIDs), paracetamol (acetaminophen), and opioids for 12 hours before brain scanning and pain sensitivity testing
• People who are willing to avoid alcohol and nicotine on the day of pain sensitivity testing and brain scanning (use after testing is finished is allowed)
• People who are willing to avoid exercise or physical activity that could cause muscle or joint soreness for 48 hours before testing (routine activity that does not cause soreness is acceptable)
• People who are able to lie still on their back for 1 hour during the MRI scan
• People who weigh 300 pounds (approximately 136 kilograms) or less

Additional criteria that must be met before moving on to the second study visit and the clinical trial:

• People who have completed more than 60% of their daily electronic diary entries (recording end-of-day pain, bleeding, and fatigue) during the lead-in period
• People who have had at least two menstrual periods during the lead-in or washout period, each separated by at least 21 days from the first day of one period to the first day of the next
• People whose daily diary entries during the lead-in period confirm moderate to severe pain both outside of and during their menstrual periods

Who may not be able to join:

• People for whom relugolix CT is medically unsuitable — for example, those with a high risk of blood clots, known bone thinning (osteoporosis), a current or past history of breast cancer or other hormone-sensitive cancers, known liver problems, unexplained abnormal uterine bleeding, or a known allergy to any ingredient in relugolix CT
• People who are currently taking part in another treatment-based clinical trial
• People who are pregnant, breastfeeding, less than 6 months since giving birth, or planning to become pregnant within the next 12 months
• People who are planning to have pelvic or abdominal surgery during the study period
• People who have had major surgery in the past 4 months involving cuts to the abdomen, chest, or head (minor procedures such as skin biopsy, hysteroscopy, or endometrial biopsy are generally acceptable — confirm with trial site)
• People who are planning to start a new pain treatment during the study (such as cognitive behavioural therapy, physiotherapy, or acupuncture); however, people who have already completed such treatments or who are on a stable, ongoing treatment may be considered eligible (confirm with trial site)
• People who have had a hysterectomy (surgical removal of the uterus) and/or surgical removal of both ovaries
• People with significant gynaecological conditions, such as abnormal uterine lining growth, an ovarian cyst larger than 5 cm, a uterus measuring more than 15 cm, or another active uterine or ovarian condition during the study period; people who have previously been successfully treated for these conditions may be considered eligible, and all participants must have had a pelvic ultrasound or MRI in the past 6 months with results available to the trial site
• People with a current or past history of psychosis, or a suicide attempt within the past 2 years (note: people with depression or anxiety are not excluded)
• People with ongoing heavy use of opioids, alcohol, or illegal drugs
• People with a history of substance misuse within the past year
• People who are unable or unwilling to stop taking opioid pain medicines at least 48 hours before the intensive study visit days
• People with certain medical conditions that could interfere with the study drug, their ability to take part safely, or their ability to follow the study requirements — including but not limited to: a body mass index (BMI) above 45, uncontrolled autoimmune or inflammatory conditions, significant heart or lung disease (such as angina, heart failure, uncontrolled high blood pressure, severe heart valve disease, COPD, or chronic asthma), kidney or liver disease (such as cirrhosis or hepatitis), uncontrolled hormonal or allergy conditions (such as uncontrolled hypothyroidism, diabetes, or allergic rhinitis), neurological conditions (such as multiple sclerosis, prior stroke, or a brain tumour), severe physical disability (such as blindness, deafness, or paraplegia), or an active cancer (other than a localised skin cancer)
• People where the study coordinator or principal investigator determines that safe or satisfactory completion of the study would not be possible
• People who are currently receiving, or in the process of applying for, disability compensation or other benefits that could be considered a secondary gain, based on self-report
• People with severe claustrophobia that prevents them from having an MRI or completing pain testing during scanning
• People with a diagnosed condition affecting the nerves in their hands or feet (peripheral neuropathy)
• People with a diagnosed condition causing seizures (epilepsy)
• People with diagnosed or self-reported migraines triggered by visual stimuli will not be able to take part in the visual testing portion of the study (confirm with trial site whether participation in other parts of the study may still be possible)
• People who weigh more than 300 pounds (approximately 136 kilograms)

Important: Always verify eligibility with the trial site directly before applying.