Why is this study being conducted?
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.
What will happen in this study?
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.
Who is eligible to participate in this study?
To be eligible for this study, at a minimum you must:
- Be a premenopausal woman 18 to 50 years of age and have normal, regular menstrual cycles that are between 21 and 35 days
- Be sexually active and have requested contraception (birth control) from your doctor to avoid pregnancy (to be considered “sexually active” in this study you must be having vaginal intercourse at least once per month with a male partner who is not known to be infertile)
- Have a diagnosis of either uterine fibroids with heavy menstrual bleeding or endometriosis with associated moderate to severe pain
- Be willing to use an investigational product as the sole method of contraception for one year (for example: condoms, diaphragms, and withdrawal are not allowed)
- Agree to complete a daily electronic diary (eDiary)
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.
