Spots Global Cancer Trial Database for A Study of Progenta (CDB-4124) in Pre-menopausal Women With Symptomatic Leiomyomata

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

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

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 Symptomatic Leiomyomata

Study ID: NCT01069094

Conditions

Uterine Leiomyomata

Interventions

Progenta

Lucron Depot

Placebo

Study Description

Brief 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.