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

23:55 EDT 16th April 2014 | BioPortfolio

Summary

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Conditions

Hypoactive Sexual Desire Disorder

Intervention

Testosterone Spray 5% and 1%, Intrinsa® Patch and Testosterone Spray 5%, Intrinsa® Patch and Testosterone Spray 1%

Location

MDS Pharma Services
Tempe
Arizona
United States
85283

Status

Terminated

Source

VIVUS, Inc.

Results (where available)

View Results

Links

Medical and Biotech [MESH] Definitions

An electrophysiologic technique for studying cells, cell membranes, and occasionally isolated organelles. All patch-clamp methods rely on a very high-resistance seal between a micropipette and a membrane; the seal is usually attained by gentle suction. The four most common variants include on-cell patch, inside-out patch, outside-out patch, and whole-cell clamp. Patch-clamp methods are commonly used to voltage clamp, that is control the voltage across the membrane and measure current flow, but current-clamp methods, in which the current is controlled and the voltage is measured, are also used.

Steroidal compounds related to TESTOSTERONE, the major mammalian male sex hormone. Testosterone congeners include important testosterone precursors in the biosynthetic pathways, metabolites, derivatives, and synthetic steroids with androgenic activities.

A medicated adhesive patch placed on the skin to deliver a specific dose of medication into the bloodstream.

A potent androgenic metabolite of TESTOSTERONE. Dihydrotestosterone (DHT) is generated by a 5-alpha reduction of testosterone. Unlike testosterone, DHT cannot be aromatized to ESTRADIOL therefore DHT is considered a pure androgenic steroid.

Skin tests in which the sensitizer is applied to a patch of cotton cloth or gauze held in place for approximately 48-72 hours. It is used for the elicitation of a contact hypersensitivity reaction.

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