Determination of the Lowest, Safe and Effective Dose of the Anti-Progestin, Proellex, in Healthy Women
| Status: | Archived |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | August 2010 |
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
The purpose of this study is to determine the effects of five different doses of Proellex on
menses, ovulation, liver function, and steady state exposure in women of reproductive age.
A phase I/II, 5 arm, single blind study, comparing five doses of Proellex to matching
placebo in healthy adult female subjects of reproductive age. Exposure to study drug will be
for up to 10 weeks. In-clinic pharmacokinetic (PK) assessments will be made on the first day
of dosing and on the last day (week 10). Office visits will occur every week to assess liver
function and trough blood concentrations for Proellex and primary metabolite. Daily vaginal
bleeding diaries will be maintained during the course of the study. A single blind run-in
period of up to 56 days will begin the study to assess baseline menstrual patterns will be
utilized. Twelve subjects per treatment group (total 60 subjects) will be assigned to each
dose. New groups will not begin dosing until the previous dose group has completed. Daily
treatments will be either 1 mg, 3 mg, 6 mg, 9 mg, 12 mg Proellex. A single blind run-in
period using placebo will be incorporated to establish baseline parameters.
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