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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
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.
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: FEMALE
Healthy Volunteers: No
Medical University /MTZ Clinical Research Sp.zo.o., Warsaw, , Poland
Name: Ronald Wiehle, PhD
Affiliation: Repros Therapeutics Inc.
Role: STUDY_DIRECTOR