NCT01096329

A Pharmacokinetic (PK) Study to Compare the Absorption of Two Formulations of Transdermal Testosterone Spray and Intrinsa®

A Phase 1, Open-label, Randomized, Three-cohort, Two-period Crossover Study to Determine the Relative Bioavailability of Testosterone Following Application of Two Testosterone Transdermal Spray (TTS) Formulations Once Daily and Intrinsa® Patch Twice Weekly in Healthy, Surgically and Naturally Post-menopausal Women Receiving Estrogen Replacement Therapy

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: VIVUS LLC · Industry
• Sex: Female
• Age: 45 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine if the absorption of the testosterone spray is the same as the Intrinsa® Patch.

Conditions

• Hypoactive Sexual Desire Disorder

Interventions

Type	Name	Description
DRUG	Testosterone Spray 5% and 1%	Testosterone Spray 5% 2x90uL for 14 days Testosterone Spray 1% 2x90uL for 14 days
DRUG	Intrinsa® Patch and Testosterone Spray 5%	Testosterone Spray 5% 2x90uL for 14 days Intrinsa® Patch for 14 days
DRUG	Intrinsa® Patch and Testosterone Spray 1%	Testosterone Spray 1% 2x90uL for 14 days Intrinsa® Patch for 14 days

Timeline

• Start date: 2010-02-01
• Primary completion: 2010-04-01
• First posted: 2010-03-31
• Last updated: 2011-06-08

Locations

1 site across 1 country: United States