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
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Assess the safety of Progenta when administered in pre-menopausal women with symptomatic leiomyomata.
Ronald Wiehle, PhD
Repros Therapeutics Inc.
United States: Food and Drug Administration