NCT02323646.
Trial name or title | A Phase 2 Study to Evaluate the Safety and Efficacy of Proellex (Telapristone Acetate) Administered Vaginally in the Treatment of Uterine Fibroids |
Methods | Randomised controlled trial |
Participants | Premenopausal women with symptomatic uterine fibroids |
Interventions | Two vaginal doses of Proellex (6 mg vs 12 mg vs placebo) administered for up to 2 courses of treatment (18 weeks each), each separated by an off‐drug interval (ODI) |
Outcomes | Percentage of participants who become amenorrhoeic after 1 course of treatment (6 months) |
Starting date | December 2014 |
Contact information | Repros Therapeutics Inc |
Notes |