At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 499 enrolled
Drug / intervention
Androxaldrug
Likely dose
Androxal 12.5 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.
An Open Label, Escalating Dose, 6 Month Phase III Safety Study Of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism
In Brief
A Phase 3 clinical trial evaluating Androxal for Secondary Hypogonadism. Completed, enrolled 499 participants across 31 sites.
Detailed Summary
ZA-300 is meant to determine the safety profile of Androxal (enclomiphene citrate) in men with secondary hypogonadism.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSecondary Hypogonadism
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedFeb 2012
Enrollment StartMay 2012
Primary CompletionOct 2013
TodayJul 2026
First PostedFeb 16, 2012
Enrollment StartMay 1, 2012
Primary CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 14.4 years ago
Interventions
Androxaldrug
Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated