NCT00975650

Efficacy and Tolerability of an Intra-Nasal Testosterone Product

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Acerus Pharmaceuticals Corporation · Industry
• Sex: Male
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Hypogonadism

Interventions

Type	Name	Description
DRUG	Nasobol®	Intra-nasal Testosterone (2 syringes), b.i.d.
DRUG	Androderm® (Positive Control)	QD administration

Timeline

• Start date: 2009-08-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2009-09-11
• Last updated: 2018-08-13
• Results posted: 2018-08-13

Locations

6 sites across 1 country: United States