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:

• You are a woman who has not yet gone through menopause, aged 18 to 50 years old
• You have been diagnosed with uterine fibroids (confirmed by a scan or medical records) and experience heavy periods that negatively affect your daily life, OR you have been diagnosed with endometriosis that causes moderate to severe pain
• If there is any chance you could become pregnant, you are willing to use non-hormonal birth control methods for the full 4 years of the treatment period
• You have a negative pregnancy test at both your screening appointment and your study entry appointment
• You are in good overall physical and mental health, based on your medical history, physical exams, lab tests, and other assessments
• Your body weight falls within a healthy range, with a Body Mass Index (BMI) of 18 or above

Who may not be able to join:

• Your body size or weight exceeds the limits of the bone density scanning equipment used in the trial, or a condition prevents a proper bone density scan of your lower spine or hip
• Your bone density scan results show that your bones are below a certain level of strength (confirm with trial site for specific values that apply to your situation)
• Your vitamin D blood level is very low (below 12 ng/mL); note that slightly low levels may still be acceptable if you are already taking or willing to start vitamin D supplements (confirm with trial site)
• You have, or have had, certain health conditions affecting your bones, hormones, or kidneys — including Cushing's Syndrome, Rheumatoid Arthritis, bone metabolism disorders, untreated overactive parathyroid or thyroid glands, Paget's disease of the bone, Marfan's syndrome, certain forms of Ehlers-Danlos syndrome, kidney disease at stage 3 or above, high prolactin levels, a known pituitary tumour, anorexia nervosa, bulimia (within the last year), or abnormal phosphate levels (some of these may be acceptable if successfully treated — confirm with trial site)
• You have a history of a bone fracture caused by a minor injury or fall (sometimes called a fragility fracture)
• You are currently taking or have previously taken medication specifically to treat bone loss (other than calcium or vitamin D supplements)
• You have used certain hormonal medications for extended periods in the past, including a specific type of injectable contraceptive for more than 2 years within the last 5 years, or certain hormone-blocking treatments for more than 12 months in total (confirm with trial site for exceptions)
• You have a condition that affects how your body absorbs nutrients, such as inflammatory bowel disease or a history of gastric bypass surgery
• You currently have breast cancer, have had breast cancer or another hormone-sensitive cancer in the past, are considered at increased risk for such cancers, or are taking medication to treat or prevent breast cancer
• You have a history of an organ transplant or bone marrow transplant
• A recent mammogram (within the last 6 months) showed results that require follow-up or further investigation (BIRADS score of 3 or higher — confirm with trial site)
• You have a known HIV infection or are considered at high risk of contracting HIV
• You have a current psychiatric condition that, in the opinion of the study doctor, could affect your ability to participate fully or could make it difficult to assess your results
• You are currently using a hormonal intrauterine device (IUD), hormonal implant, hormonal contraceptive, or other prohibited medication and are not willing to stop using it

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