Inactive Studies
Proellex® - PK Bridging (ZP-002): Proellex® Pharmacokinetic Bridging Study II (Study Completed)
Proellex® - PK Bridging (ZP-002): Proellex® Pharmacokinetic Bridging Study II (Study Completed)
Purpose: This is an open-label, randomized, single-center, outpatient, unblinded, single-dose, three-way crossover study of the safety and PK properties of Proellex® in women ages 18 - 34 years. Safety will be assessed throughout the study.
Proellex® - Safety and PK (ZP-003): A Safety and Pharmacokinetic (PK) Study of Proellex® (Study Completed)
Purpose: This is an open-label, single-center, outpatient, unblinded, multi-dose study of the safety and pharmacokinetic properties of Proellex®. Safety will be assessed throughout the study.
Active Studies
Proellex® Uterine Fibroids (ZP-005): Evaluate the Safety and PK of Proellex® in Female Patients With Impaired Hepatic Function and Healthy Adults
Purpose: This study will evaluate the safety and pharmacokinetics of two doses of orally administered Proellex® in female patients with impaired hepatic function and healthy volunteers with normal hepatic function.
Proellex® - Endometriosis (ZPE-201): Safety and Efficacy Study to Evaluate Proellex® in the Treatment of Premenopausal Women with Symptomatic Endometriosis
Purpose: The purpose of this study is to determine whether Proellex® is safe and effective for the treatment of symptomatic endometriosis.
Proellex® Uterine Fibroids (ZPU-202): Pharmacokinetics, Safety and Efficacy Study of Proellex in Pre-Menopausal Women With Symptomatic Uterine Fibroids
Purpose: The primary objective is to evaluate the pharmacokinetics (PK) of 25mg and 50mg Proellex® administered once daily (QD) over a 4-month period.
Proellex® Uterine Fibroids - Anemia (ZPU-301): Safety and Efficacy of Proellex® in Pre-Menopausal Anemic Women With Symptomatic Uterine Fibroids
Purpose: To determine the efficacy of 25 mg and 50 mg daily oral doses of Proellex® versus daily oral doses of placebo in the treatment of anemia in subjects with symptomatic uterine fibroids.
Proellex® Uterine Fibroids (ZPU-303): Evaluating the Safety and Efficacy of Proellex® (CDB-4124) in Premenopausal Women With Symptomatic Uterine Fibroids
Purpose: The purpose of this study is to analyze the safety and effectiveness between 50mg versus placebo, and between 25mg and placebo in Premenopausal women with symptomatic uterine fibroids.
Proellex® Uterine Fibroids (ZPU-305): Safety Study to Evaluate Proellex® in Premenopausal Women With Uterine Fibroids
Purpose: The purpose of this study is to evaluate the safety of Proellex®, administered once daily for three treatment cycles (four months each).
Androxal® - Secondary Hypogonadism (ZA-201): To Evaluate Fertility in Men with Secondary Hypogonadism (AIHH*) Previously Treated with Topical Testosterone
Purpose: To determine if Androxal® can reverse the suppression of the hypothalamic-pituitary axis and secretion of pituitary hormones (LH and FSH) which stimulate testosterone production and Sertoli cell number, thereby restoring sperm count. Twelve subjects per group will be randomized to daily treatments of Androxal® or topical testosterone (Testim®) for six months. These men must have been previously treated with exogenous testosterone.