NCT01962805

Comparison of Two Formulations of Proellex for Vaginal Administration

A Double-Blind, Crossover Study in Healthy Volunteers to Compare Two Formulations of Proellex for Vaginal Administration

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Repros Therapeutics Inc. · Industry
• Sex: Female
• Age: 18 Years – 47 Years
• Healthy volunteers: Accepted

Summary

This study is a double-blind crossover study in female healthy volunteers to compare the pharmacokinetics and safety of either 1 or 6 days of dosing with two different formulations of Proellex for vaginal administration. Each formulation will be designated as either Treatment A or Treatment B. A total of 8 subjects who meet the eligibility criteria will be randomized to receive either Treatment A or Treatment B as their first assigned treatment. Subjects will receive a single dose of Treatment A or daily dosing with Treatment B for 6 days. After a 7-day washout period subjects will receive the alternative treatment. On the day of treatment with Treatment A and on the first and last days of treatment with Treatment B subjects will remain in the clinic overnight and undergo 32-hour pharmacokinetic assessment at the following time points: 0, 0.5, 1, 2, 4, 8, 12, 16, 20, 24, 28 and 32 hours after administration of study drug. For Treatment B study drug will be administered in the clinic each day after a trough blood sample has been drawn.

Conditions

• Comparison of 2 Different Formulations of 12 mg Proellex Vaginal Capsules

Interventions

Type	Name	Description
DRUG	Proellex Formulation A
DRUG	Proellex Formulation B

Timeline

• Start date: 2013-10-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2013-10-14
• Last updated: 2014-01-24

Locations

1 site across 1 country: United States