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

07:29 EDT 31st July 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

Clinical Trials [733 Associated Clinical Trials listed on BioPortfolio]

Do Treatments for Smoking Cessation Affect Alcohol Drinking? Study 1: Nicotine Replacement Therapy

This study examines the effect of combined nicotine replacement therapy (transdermal patch + nasal spray vs. transdermal patch + placebo nasal spray) on reactivity to alcohol and self-admi...

Study of Transdermal Testosterone Patches in Surgically Menopausal Women With Low Libido

This study is designed to evaluate efficacy and safety of a testosterone patch as treatment for low libido in surgically menopausal women who are taking estrogen therapy.

Bioequivalence of Testosterone Reduced-size Patch Relative to the Testosterone Reference Patch

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...

Study of Transdermal Testosterone Patches in Naturally Menopausal Women With Low Libido

This study is designed to evaluate efficacy and safety of a testosterone patch as treatment for low libido in naturally menopausal women who are taking estrogen or estrogen/progestin thera...

Endometrial Safety Study of Transdermal Testosterone (300 Mcg/Day) in Naturally Postmenopausal Women

This study is designed to evaluate the endometrial safety of a testosterone patch as treatment for low libido in naturally postmenopausal women.

PubMed Articles [1074 Associated PubMed Articles listed on BioPortfolio]

Implications of off-label use: An example from the final results of an observational cohort study on Intrinsa® (testosterone patch).

Off-label use is where a medicinal product is used for a medical purpose not in accordance with the authorised product information. Intrinsa® is a transdermal testosterone patch, which is indicated f...

Combination Rapid-Acting Nicotine Mouth Spray and Nicotine Patch Therapy in Smoking Cessation.

Improved smoking cessation rates are urgently required if New Zealand is to reach its target of a smokefree nation by 2025, during which some 600,000 smokers will need to quit. Nicotine replacement th...

Progressive Improvement of T-Scores in Men with Osteoporosis and Subnormal Serum Testosterone Levels upon Treatment with Testosterone over Six Years.

Testosterone deficiency leads to bone loss and testosterone treatment has a beneficial effect. This study investigated the effects of normalizing serum testosterone on bone mineral density in 45 men w...

Paper spray-MS for bioanalysis.

This Review provides a general understanding of paper spray-MS, including the methodology and theory associated with a number of different related applications. This method has become a direct samplin...

Effect of Adiantum Capillus veneris Linn on an Animal Model of Testosterone-Induced Hair Loss.

Androgenetic alopecia is the most common form of hair loss in men. The present study was designed to evaluate the hair growth-promoting activity of a preparation of the Adiantum capillus-veneris Linn....

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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