At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 306 enrolled
Drug / intervention
Testosterone +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Testosterone for Male Hypogonadism. Completed, enrolled 306 participants across 30 sites.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMale Hypogonadism
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2011
First PostedOct 2011
Primary CompletionDec 2012
Study CompletionMar 2013
TodayJul 2026
First PostedOct 4, 2011
Enrollment StartSep 1, 2011
Primary CompletionDec 1, 2012
Study CompletionMar 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 14.7 years ago
Interventions
Testosteronedrug
Intranasal testosterone
Testosteronedrug
Intranasal testosterone