Clinical Trial: A Study of Progenta (CDB-4124) in Pre-menopausal Women With Symptomatic Leiomyomata

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

Official Title: A Single Dose lead-in PK Followed by a Randomized, Double-blinded, Controlled, Multiple Dose Study of the Selective Progesterone Receptor Modulator Progenta (CDB-4124) in Pre-menopausal Women With Sym

Brief Summary: A study of 3 doses of Progenta versus placebo versus Lucron Depot for treatment of leiomyomata.

Detailed Summary: Three doses of Progenta (CDB4124 - 12.5, 25, 50 mg) versus placebo versus Lucron Depot (leuprolide acetate for depot suspension) was initiated in females with symptomatic leiomyomata. A single dose PK visit was conducted only for subjects randomized to the Progenta arm, between screening and visit 1. A second PK assessment was conducted at Visit 3 (one month on drug) to collect steady state data. Treatment period lasted for 3 months.
Sponsor: Repros Therapeutics Inc.

Current Primary Outcome: Assess the safety of Progenta when administered in pre-menopausal women with symptomatic leiomyomata. [ Time Frame: 90 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Determine the tolerability of three doses of Progenta (12.5 mg, 25 mg, and 50 mg) as compared to placebo and Lucron Depot (leuprolide acetate for depot suspension) in pre-menopausal women with symptomatic leiomyomata. [ Time Frame: 90 days ]

Original Secondary Outcome: Same as current

Information By: Repros Therapeutics Inc.

Dates:
Date Received: February 12, 2010
Date Started: July 2004
Date Completion:
Last Updated: June 27, 2014
Last Verified: June 2014