We invite you to join us for an informational presentation about the latest advances in treatment options for uterine fibroids.
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In this study, doctors want to learn more about the safety and effectiveness of an investigational drug to prevent pregnancy in women 18 to 50 years of age with uterine fibroids or endometriosis. Uterine fibroids are noncancerous growths of the uterus. Endometriosis is when tissue similar to the lining of the uterus (also called the endometrium) grows on the walls of the abdominal and pelvic cavities, ovaries, bowel, and other organs in the pelvis. The results from this study will help women and their doctors make informed decisions about the need to use additional contraception (birth control) while being treated with this investigational drug.
In this study, you will take the investigational drug by mouth once daily for up to 1 year. No other form of contraception (for example, condoms, pills, patches, or rings) is allowed during participation in the study. Throughout the study, you will complete an eDiary questionnaire daily and take a home pregnancy test every 28 days. The study site staff will provide training for the eDiary and tell you how to take the study medication and the home pregnancy test. You will be in this study for a little over 2 years. During these 2 years, you will have both a treatment period and a post-treatment follow-up period, which would require you to come to the study center at least 10 times during the study. During the treatment period, you will take the investigational drug daily for up to 1 year and have both on-site visits and safety follow-up visits by phone. After the treatment period is the post-treatment follow-up period to monitor bone mineral density, which consists of 3 on-site visits over 1 year.
To be eligible for this study, at a minimum you must:
This is not a complete list of study eligibility requirements. The study doctor will review the full requirements for this study with you.
You will receive all study-related procedures and the investigational product at no cost.
To learn more about this study, or to find out if you qualify, call 303-321-2255.