At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 314 enrolled
Drug / intervention
SOV2012-F1 +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 12-Month, Randomized, Active-controlled, Open-label Study of the Efficacy and Safety of Oral Testosterone Undecanoate in Hypogonadal Men (RE-TUne)
In Brief
A Phase 3 clinical trial evaluating SOV2012-F1 and AndroGel for Hypogonadism, Male. Completed, enrolled 314 participants across 36 sites.
Detailed Summary
This will be a randomized, multicenter, open-label, active-controlled, efficacy, and safety study in adult hypogonadal men. The study duration is 12 months (365 days), including a 90-day, open-label efficacy period and a 9-month (275-day) safety evaluation period.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypogonadism, Male
CountriesUnited States
CollaboratorsSyneos Health
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedJun 2017
Enrollment StartJul 2017
Primary CompletionMay 2020
TodayJul 2026
First PostedJun 26, 2017
Enrollment StartJul 5, 2017
Primary CompletionMay 1, 2020
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 9.0 years ago
Interventions
SOV2012-F1drug
oral preparation of testosterone undecanoate (TU)
AndroGeldrug
topical testosterone gel 1.62%