NCT01446042

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 306 (actual)
• Sponsor: Acerus Pharmaceuticals Corporation · Industry
• Sex: Male
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Male Hypogonadism

Interventions

Type	Name	Description
DRUG	Testosterone	Intranasal testosterone
DRUG	Testosterone	Intranasal testosterone

Timeline

• Start date: 2011-09-01
• Primary completion: 2012-12-01
• Completion: 2013-03-01
• First posted: 2011-10-04
• Last updated: 2018-06-13
• Results posted: 2018-06-13

Locations

30 sites across 1 country: United States