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Safety and Efficacy of Intranasal TBS-1 Treatment of Male Hypogonadism

Male Hypogonadism Clinical Trial

Official title:
A 90-Day, Randomized, Dose-Ranging Study, Including Potential Dose Titration, Evaluating the Efficacy and Safety of Intranasal TBS-1 in the Treatment of Male Hypogonadism With Sequential Safety Extension Periods of 90 and 180 Days

Clinical Trial Summary

The purpose of this study is to determine the efficacy (based on the pharmacokinetic profile of testosterone) and safety of TBS-1 in the treatment of hypogonadal men

Clinical Trial Description

This study is a 4 Period study consists of 16 visits with overnight clinic stays that span over year to help determine the efficacy of TBS-1 gel administered twice daily (b.i.d) and three times daily (t.i.d)

In addition, this study will investigate the safety and tolerability of TBS-1 after 90, 180 and 360 days of treatment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01446042
Study type Interventional
Source Acerus Pharmaceuticals Corporation
Contact
Status Completed
Phase Phase 3
Start date September 2011
Completion date March 2013
View Details
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