At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 531 enrolled
Drug / intervention
Testosterone Undecanoate 750 mg +1 moredrug
Likely dose
Testosterone Undecanoate 750 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.
A Two-Arm, Open-Label, Randomized, Multi-Center Pharmacokinetic and Long-Term Safety Study of Intramuscular Injections of 750 mg and 1000 mg Testosterone Undecanoate in Hypogonadal Men
In Brief
A Phase 3 clinical trial evaluating Testosterone Undecanoate 750 mg and Testosterone Undecanoate 1000 mg for Hypogonadism and 2 related conditions. Completed, enrolled 531 participants across 1 site.
Detailed Summary
To evaluate the pharmacokinetics of TU 750 mg and TU 1000 mg via multiple measurements of serum total testosterone.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypogonadism, Primary Hypogonadism, Secondary Hypogonadism
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMar 2006
First PostedMay 2007
Primary CompletionJul 2009
TodayJul 2026
First PostedMay 1, 2007
Enrollment StartMar 1, 2006
Primary CompletionJul 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 19.2 years ago
Interventions
Testosterone Undecanoate 750 mgdrug
Testosterone Undecanoate 1000 mgdrug