NCT00683917

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Repros Therapeutics Inc. · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Uterine Fibroids

Interventions

Type	Name	Description
DRUG	Proellex 25 mg	Proellex 25 mg, 1 capsule daily for 4 months
DRUG	Proellex 50 mg	Proellex 50 mg, 2 capsules daily for 4 months
DRUG	Lupron Depot	Lupron 3.75 mg monthly intramuscular injections for 4 months

Timeline

• Start date: 2008-05-01
• Primary completion: 2009-08-01
• Completion: 2009-08-01
• First posted: 2008-05-26
• Last updated: 2014-08-21
• Results posted: 2014-08-21

Locations

4 sites across 2 countries: United States, Mexico