At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 182 enrolled
Drug / intervention
Oral testosterone undecanoate +1 moredrug
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.
Open-Label Study of Oral Testosterone Undecanoate (TU) in Hypogonadal Men
In Brief
A Phase 3 clinical trial evaluating Oral testosterone undecanoate and Transdermal testosterone gel (AndroGel) for Male Hypogonadism. Completed, enrolled 182 participants across 30 sites in 2 countries.
Detailed Summary
The purpose of this one year extension (follow-up) study is to gather additional safety data in hypogonadal men treated with oral TU or AndroGel who have completed the 12-month Phase III study CLAR-09007.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMale Hypogonadism
CountriesGermany, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartAug 2012
First PostedOct 2012
Primary CompletionApr 2014
TodayJul 2026
First PostedOct 3, 2012
Enrollment StartAug 1, 2012
Primary CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 13.7 years ago
Interventions
Oral testosterone undecanoatedrug
Total daily dose of T = 200 mg T (as 316 mg TU) to 600 mg T (as 948 mg TU), taken as 100 mg to 300 mg T BID
Transdermal testosterone gel (AndroGel)drug
Total daily dose of T = 2.5 to 10 g of gel (25 mg to 100 mg T) QD