NCT01069094

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

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 Symptomatic Leiomyomata

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Repros Therapeutics Inc. · Industry
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Uterine Leiomyomata

Interventions

Type	Name	Description
DRUG	Progenta	12.5 mg, administered as a once daily oral dose for 90 days.
DRUG	Progenta	25 mg, administered as a once daily oral dose for 90 days.
DRUG	Progenta	50 mg, administered as a once daily oral dose for 90 days.
DRUG	Lucron Depot	3.75 mg IM monthly
DRUG	Placebo	Administered as a once daily oral dose for 90 days.

Timeline

• Start date: 2004-07-01
• Primary completion: 2005-01-01
• Completion: 2005-01-01
• First posted: 2010-02-17
• Last updated: 2014-06-30

Locations

1 site across 1 country: Poland