NCT00702702

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Repros Therapeutics Inc. · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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. Study was terminated by clinical hold.

Conditions

• Uterine Fibroids
• Anemia

Interventions

Type	Name	Description
DRUG	Proellex 25 mg	Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months
DRUG	Proellex 50 mg	Proellex 50 mg, 2 - 25 mg capsules daily for 3 months
DRUG	Placebo	Placebo, 2 capsules daily for 3 months

Timeline

• Start date: 2008-06-01
• Primary completion: 2009-08-01
• Completion: 2009-08-01
• First posted: 2008-06-20
• Last updated: 2014-08-21
• Results posted: 2014-08-21

Locations

30 sites across 1 country: United States