An Escalating Dose, Single-Blind, Placebo Run-in, Phase I/II Study in Healthy Women, Comparing Five Oral Doses of the Anti-progestin, Proellex® (Telapristone Acetate, CDB-4124), Impact on Induction of Amenorrhea, Liver Function, and Assessment of Steady State Exposure
Status: Currently enrolling subjects
Purpose: To determine the effects of five different doses of Proellex on menses, ovulation, liver function, and steady state exposure in women of reproductive age.
Eligibility:
- Healthy females, ages 18 years to 50 years with regular menstrual cycles (subjects with excessive menstrual bleeding and/or pain are eligible to participate)
Study Drug: Proellex® 1mg, 3mg, 6mg, 9mg and 12mg in escalating doses
Study Design: Treatment, Randomized, Single-Blind, Placebo Control, Crossover Assignment, Safety and Efficacy
Primary Outcome Measures:
- To establish the minimum dose required to suppress ovulation and/or menses, measured by using ovulation timing kits and daily diary for bleeding
- To monitor signals of potential liver toxicity over a 10 week period of active dosing in 5 treatment groups
For more information, please visit www.clinicaltrials.gov. If you meet the study criteria and are interested in participating in the study, please contact:
Study Director:
Ronald Wiehle, Ph.D.
Repros Therapeutics Inc.
281-719-3400
Current Clinical Site Locations:
- San Antonio, Texas