The drug we are studying is a GnRH receptor antagonist combined with estrogen and progesterone. In this study we want to learn if the investigational drug is a safe and effective option for pregnancy prevention specifically in women with uterine fibroids and endometriosis. If enrolled, you will receive the medication being tested in this study for one year. The study drug is taken by mouth once daily. You will not be allowed to use any other form of birth control for the duration of the study including condoms or withdrawal/”the pull-out method”. Following one year of treatment, you will be required to undergo two post-treatment follow-up bone mineral density scans at 6-months and 12-months after treatment completion. Your total participation will last approximately 2 years and you will be asked to attend 8 doctor’s visits and complete 4 follow-up phone calls. You will keep a daily electronic diary to record drug intake.
- Premenopausal women between the ages of 18 and 50
- Diagnosed with uterine fibroids or endometriosis
- Is at risk for pregnancy
- Willing to use the study drug as sole method of contraception
- Willing and able to complete a daily eDiary
- Additional criteria apply
Qualified participants may be compensated up to $ 2,150.00 for time and travel