A Phase 3, Single Arm, Open Label Study to Evaluate the Safety and Contraceptive Efficacy of Relugolix Combination Therapy in Women with Uterine Fibroids or Endometriosis Who Are 18 to 50 Years of Age and at Risk of Pregnancy
To asses the safety and contraceptive effectiveness of a combination medication of Myfembree and birth control.
Women volunteers that have endometriosis or fibroids are needed for us to learn more about the effects of a combination therapy containing Myfembree (relugolix) and a birth control medication.
Participants will have:
-Endometriosis or Fibroids
-Aged 18-49 years old
-Have regular menstrual cycles
-Be at risk of pregnancy
-Be able and willing to complete a daily electronic diary (provided)
Main Procedures Involved: -11 study visits over 2 years
-History & Physical
-Study Medication provided for approximately 1 year
-Dexa exams to look at bone density
-Surveys on an electronic diary
Duration of Participation: 1 year of active study participation and 1 year of follow-up
18 to 49 years
Treatment
Compensation Provided
Free Parking
Jill Liss, MD
Protocol Number: 22-1377
More information available at ClinicalTrials.gov: NCT04756037
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