At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 16 enrolled
Drug / intervention
Oral testosterone undecanoate (containing 300 mg T)drug
Likely dose
Oral testosterone undecanoate (containing 300 mg T)from 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 II Study of the Effect of Food With Various Levels of Fat on the Pharmacokinetics of an Oral Testosterone Undecanoate Formulation in Hypogonadal Men
In Brief
A Phase 2 clinical trial evaluating Oral testosterone undecanoate (containing 300 mg T) for Male Hypogonadism. Completed, enrolled 16 participants across 2 sites in 2 countries.
Detailed Summary
The purpose of the study is to determine the effect of food with various amounts of fat on the absorption of an oral testosterone undecanoate formulation.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMale Hypogonadism
CountriesCanada, United States
Collaborators--
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 2009
Enrollment StartJul 2009
Primary CompletionSep 2009
Study CompletionJul 2010
TodayJul 2026
First PostedJun 19, 2009
Enrollment StartJul 1, 2009
Primary CompletionSep 1, 2009
Study CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 17.0 years ago
Interventions
Oral testosterone undecanoate (containing 300 mg T)drug