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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
110
28 cm2 testosterone patch, each patch is on for 4 days, 3 patches are used
14 cm2 testosterone patch, each patch is on for 4 days, 3 patches are used
Antonio Pizarro, MD
Fort Myers, Florida, United States
Maria J Gulierrez, MD
Miramar, Florida, United States
David R Mathews, MD
Overland Park, Kansas, United States
Robert J Schwab, MD
Omaha, Nebraska, United States
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
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