Clinical Trial: Determination of the Lowest, Safe and Effective Dose of Proellex

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Single-Blind, Placebo Run-in, Phase I/II Study Comparing Five Oral Doses of Proellex®

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: Repros Therapeutics Inc.

Current Primary Outcome: Induction Amenorrhea [ Time Frame: 10 weeks ]

Induction of amenorrhea as determined by suppression of ovulation and/or menses, measured by using ovulation timing kits and daily diary for bleeding. Five doses will be compared in an escalating-dose, to independent groups, to a run-in placebo treatment period.


Original Primary Outcome:

  • Induction Amenorrhea [ Time Frame: 10 weeks ]
    Induction of amenorrhea as determined by suppression of ovulation and/or menses, measured by using ovulation timing kits and daily diary for bleeding. Five doses will be compared in an escalating-dose, to independent groups, to a run-in placebo treatment period.
  • Affected liver function [ Time Frame: weekly ]
    Determine if any signal for liver toxicity can be detected after 8 weeks of dosing at any dose


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Repros Therapeutics Inc.

Dates:
Date Received: August 20, 2010
Date Started: August 2010
Date Completion:
Last Updated: June 27, 2014
Last Verified: June 2014