NCT00791856

Bioequivalence of Testosterone Reduced-size Patch Relative to the Testosterone Reference Patch

An Open-label, Multiple-dose, Randomized, Two-period Crossover Study to Assess Bioequivalence of the 300 Mcg/Day Testosterone Reduced-size Patch (14 cm2) Relative to the 300 Mcg/Day Testosterone Reference Patch (28 cm2)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Warner Chilcott · Industry
• Sex: Female
• Age: 20 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This is an open-label, multiple-dose, randomized, two-period crossover bioequivalence study in approximately 110 surgically or naturally postmenopausal women on stable hormone therapy (i.e., estrogen for surgically postmenopausal women or a continuous regimen of estrogen plus progestin for naturally postmenopausal women) restricted to approved oral or transdermal regimens only, or not on concomitant hormone therapy.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	testosterone	28 cm2 testosterone patch, each patch is on for 4 days, 3 patches are used
DRUG	testosterone	14 cm2 testosterone patch, each patch is on for 4 days, 3 patches are used

Timeline

• Start date: 2007-07-01
• Primary completion: 2008-05-01
• Completion: 2008-05-01
• First posted: 2008-11-17
• Last updated: 2013-04-17

Locations

4 sites across 1 country: United States