Summary:
A phase 2, multi-center, three-arm, Parallel design, randomized, double-blind study to evaluate the safety and efficacy of 6 and 12 mg proellex® (telapristone acetate) administered orally in the treatment of premenopausal women with confirmed Symptomatic Endometriosis.
This study will last about 7 months and involve up to 13 visits. You will be asked to make visits to the
study site every 2 weeks. There will be a total of 90 women, ages 18 to 47, enrolled in different groups, at approximately 10 different study sites.
You may qualify for this study if:
- You Have a diagnosis of endometriosis confirmed by surgery
- Be currently using narcotic medications for treatment of pain. Narcotic analgesic use during the
study should be limited to pain relief as opposed to preventing pain
- Use 2 forms of contraception while enrolled in the study
You cannot be in this study if:
- You are in another research study
- You have received any other study drugs in the last 30 days
- You are post-menopausal
- You have an IUD in place
- You have abnormal liver function
Qualified participants may receive:
Study related medical exams/evaluations and laboratory evaluations.
You will be paid for each completed visit (see table above). You may receive up to $1450.00 for being in
the study and up to $2000.00 if you do not miss any visits, and the lab results show study drug in your
blood.** If you choose to leave or are withdrawn from the study for any reason before finishing all visits
you will be paid for each completed visit. You will receive payment within 4 weeks of your final study
visit.