Clinical Trial: Safety and Efficacy of Intranasal TBS-1 Treatment of Male Hypogonadism
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
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 Extens
Brief 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 Summary:
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.
Sponsor: Trimel Biopharma SRL
Current Primary Outcome: Serum testosterone Cavg [ Time Frame: 90 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Safety and tolerability of TBS-1 [ Time Frame: 90 days, 180 days, 360 days ]
- Effect of TBS-1 on body composition [ Time Frame: 90 days ]
- Effect of TBS-1 on bone mineral density [ Time Frame: 90 days ]
- Effect of TBS-1 on mood [ Time Frame: 90 days ]
- Effect of TBS-1 on erectile function [ Time Frame: 90 days ]
Original Secondary Outcome: Same as current
Information By: Trimel Biopharma SRL
Dates:
Date Received: September 30, 2011
Date Started: September 2011
Date Completion: December 2012
Last Updated: June 13, 2012
Last Verified: June 2012
