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Efficacy and Tolerability of an Intra-Nasal Testosterone Product

Hypogonadism Clinical Trial

Official title:
Efficacy and Tolerability of Nasobol®, an Intra-Nasal Testosterone Product, for Testosterone Replacement in Hypogonadal Men

Clinical Trial Summary

This clinical trial is being performed to compare the pharmacokinetic profile of testosterone after repeated intra-nasal administration of products of different strengths in subjects with hypogonadism.

Clinical Trial Description

Primary Objective:

The primary objective of this study was to determine the efficacy of Nasobol in the treatment of hypogonadal men requiring testosterone replacement therapy. Efficacy was determined by establishing a pharmacokinetic profile for serum testosterone levels following Nasobol treatment, and comparing it to that of the active control, Androderm®.

Secondary Objective:

To establish a safety profile for Nasobol. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00975650
Study type Interventional
Source Acerus Pharmaceuticals Corporation
Contact
Status Completed
Phase Phase 2
Start date August 2009
Completion date May 2010
View Details
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