A Pharmacokinetic (PK) Study to Compare the Absorption of Two Formulations of Transdermal Testosterone Spray and Intrinsa®
NCT01096329 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16
Last updated 2011-06-08
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
- 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
Sponsors & Collaborators
-
VIVUS LLC
lead INDUSTRY
Principal Investigators
-
Mark Allison, MD · MDS Pharma Services Inc
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 45 Years
- Max Age
- 65 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2010-02-28
- Primary Completion
- 2010-04-30
Countries
- United States
Study Locations
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