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Leuprolide

Antineoplastic Agents, Hormonal

Proellex 25 mg, 1 capsule daily for 4 months

Proellex 25 mg

Proellex 50 mg, 2 capsules daily for 4 months

Proellex 50 mg

Lupron 3.75 mg monthly intramuscular injections for 4 months

Lupron Depot

Andre vanAs, MD, PhD

PK of 25 mg and 50 mg Proellex® administered once daily (QD) over a 4-month period.

The primary objective is to evaluate the pharmacokinetics (PK) of 25 mg and 50 mg Proellex® administered once daily (QD) over a 4-month period.

Pharmacokinetics, Safety and Efficacy Study of Proellex in Pre-menopausal Women With Symptomatic Uterine Fibroids

A Multi-center, Active Controlled, Pharmacokinetic, Safety and Efficacy Study of Proellex in Pre-Menopausal Women With Symptomatic Uterine Fibroids to Assess Persistence of Response

Repros Therapeutics Inc.

Proellex 25 mg: Proellex 25 mg, 1 capsule daily for 4 months

Proellex 50 mg: Proellex 50 mg, 2 capsules daily for 4 months

Lupron Depot: Lupron 3.75 mg monthly intramuscular injections for 4 months

Lupron

Total

<=18 years

Between 18 and 65 years

>=65 years

Age, Categorical

Female

Male

Sex: Female, Male

United States

Mexico

Region of Enrollment

The study was prematurely terminated for safety reasons (Proellex studies were put on clinical hold due to liver toxicity). Sponsor was unable to pay vendor, and was therefore not provided with any study data.

Jennifer Wike

The Primary Outcome Measure is the PK Characteristics of 25 mg and 50 mg Proellex.

Proellex 25 mg: Proellex 50 mg, placebo, 1 capsule daily for 4 months Study prematurely terminated, no further data available

Proellex All Groups

Overall Study

One capsule Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle

Two capsules Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle

The safety of Proellex 25 and 50 mg administered once daily for three treatment cycles (four months each) will be evaluated.

Subjects will be randomized to either Proellex dose, 25 mg or 50 mg, in a 1:1 ratio. Subjects will receive drug for a four (4) month cycle of therapy three (3) times, each treatment cycle being separated by an off-drug interval until menstruation occurs. During the treatment periods, all subjects will be assessed monthly. Subjects will undergo an additional follow-up for 3 months following their last treatment visit.

Multicenter Study Evaluating the Safety of Proellex® in Premenopausal Women With Uterine Fibroids

A Phase III, Open-Label, Parallel, Randomized, Multicenter Study Evaluating the Safety of 25 And 50 mg Proellex® (CDB-4124) in the Treatment of Premenopausal Women With Symptomatic Uterine Fibroids

Proellex 25 mg once daily

Proellex 25 mg: One capsule Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle

25 mg Proellex

Proellex 50 mg once daily

Proellex 50 mg: Two capsules Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle

Age, Continuous

To Assess the Safety of Proellex Administered Once Daily for Three Treatment Cycles (4 Months Each Cycle)

Proellex 25 or 50 mg once daily

One capsule Proellex 25 mg or 50 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle

Proellex

Blood and Lymph Conditions

Anemia

Progesterone

Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months

Proellex 50 mg, 2 - 25 mg capsules daily for 3 months

Placebo

Andre van As, MD, PhD

Subjects will be randomly assigned to one of 3 treatment groups and receive 325 mg (65 mg elemental iron) iron supplements twice daily.

Eligible female subjects will be randomly assigned to one of the three treatment groups. Subjects will receive 325 mg (65 mg elemental iron) iron supplements to be taken twice daily during study drug treatment. The study duration is approximately six months, which is comprised of a 4 - 6 week screening period, a three-month drug treatment period, and a one-month follow-up period.

Safety and Efficacy of Proellex in Pre-Menopausal Anemic Women With Symptomatic Uterine Fibroids

A Multi-Center, Placebo Controlled, Safety and Efficacy Study of the Selective Progesterone Receptor Modulator Proellex® (CDB-4124) in Anemic, Pre-Menopausal Women With Symptomatic Uterine Fibroids Requiring Hysterectomy

Proellex 25 mg: Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months

Proellex 50 mg: Proellex 50 mg, 2 - 25 mg capsules daily for 3 months

Placebo: Placebo, 2 capsules daily for 3 months

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Pharmacokinetics, Safety and Efficacy Study of Proellex in Pre-menopausal Women With Symptomatic Uterine Fibroids	NCT00683917	Uterine Fibroid...	Proellex 25 mg Proellex 50 mg Lupron Depot	18 Years - 45 Years	Repros Therapeutics Inc.
Multicenter Study Evaluating the Safety of Proellex® in Premenopausal Women With Uterine Fibroids	NCT00737282	Uterine Fibroid...	Proellex 25 mg Proellex 50 mg	18 Years - 48 Years	Repros Therapeutics Inc.
Safety and Efficacy of Proellex in Pre-Menopausal Anemic Women With Symptomatic Uterine Fibroids	NCT00785356	Uterine Fibroid... Anemia	Proellex 25 mg Proellex 50 mg Placebo	18 Years - 48 Years	Repros Therapeutics Inc.

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