Clinical Trial: Bioequivalence of Testosterone Reduced-size Patch Relative to the Testosterone Reference Patch
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: 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 3
Brief 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.
Detailed Summary:
Sponsor: Warner Chilcott
Current Primary Outcome: Bioequivalence of two testosterone patches based on baseline-corrected (AUCτ) and baseline-corrected maximum serum concentrations of total testosterone and free testosterone at steady-state [ Time Frame: 12 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Warner Chilcott
Dates:
Date Received: November 14, 2008
Date Started: July 2007
Date Completion:
Last Updated: April 15, 2013
Last Verified: April 2013