NCT00787618

Evaluate PK and Safety of Proellex® in Females With Various Stages of Impaired Renal Function and Healthy Females

A Single-Dose, Open-Label, Parallel Group Study To Evaluate The Pharmacokinetics And Safety Profile Of PROELLEX® (CDB-4124) In Female Subjects With Various Stages Of Impaired Renal Function And In Healthy Female Volunteers

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Repros Therapeutics Inc. · Industry
• Sex: Female
• Age: 18 Years – 48 Years
• Healthy volunteers: Accepted

Summary

PK and safety profile of Proellex® in females with various stages of impaired renal function

Detailed description

The study will evaluate the pharmacokinetics and safety profile of Proellex® in females with various stages of impaired renal function and in volunteers with normal renal function

Conditions

• Renal Impairment

Interventions

Type	Name	Description
DRUG	50 mg Proellex	Single dose

Timeline

• Start date: 2008-10-01
• Primary completion: 2009-06-01
• Completion: 2009-07-01
• First posted: 2008-11-07
• Last updated: 2014-08-25
• Results posted: 2014-08-25

Locations

4 sites across 1 country: United States