At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 144 enrolled
Drug / intervention
Oral testosterone undecanoatedrug
Likely dose
Oral testosterone undecanoate 200 mgfrom 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.
Phase III, Open-label Study of the Safety and Efficacy of Oral Testosterone Undecanoate (TU)in Hypogonadal Men
In Brief
A Phase 3 clinical trial evaluating Oral testosterone undecanoate for Male Hypogonadism. Completed, enrolled 144 participants across 27 sites.
Detailed Summary
The purpose of the study is to determine if oral testosterone undecanoate is effective and safe in the treatment of low testosterone in men.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMale Hypogonadism
CountriesUnited States
CollaboratorsinVentiv Health Clinical
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartJan 2013
First PostedJan 2013
Primary CompletionJul 2013
TodayJul 2026
First PostedJan 10, 2013
Enrollment StartJan 1, 2013
Primary CompletionJul 1, 2013
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 13.5 years ago
Interventions
Oral testosterone undecanoatedrug
Initial dose 200 mg T, BID; dose titration Days 42 and/or 84 based on serum T levels obtained 3-5 hours post AM dose on Days 30 and 72. Dosages increased or decreased in 50 mg increments.