At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 151 enrolled
Drug / intervention
Androxal +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 Randomized, Double Blind, Placebo Controlled Multi-Center Phase III Study to Evaluate Normalization of Morning Testosterone Levels in Overweight Men With Acquired Hypogonadotropic Hypogonadism and Normal Sperm Concentration
In Brief
A Phase 3 clinical trial evaluating Androxal and Placebo for Secondary Hypogonadism. Completed, enrolled 151 participants across 23 sites.
Detailed Summary
The purpose of ZA-301 is to determine the effects of Androxal on morning testosterone and reproductive status in younger overweight men with acquired hypogonadotropic hypogonadism (confirmed morning T\<300 ng/dL) and normal sperm concentration, compared to changes with placebo. Subjects must not have previously been treated with testosterone products within the last 6 months.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSecondary Hypogonadism
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedFeb 2012
Enrollment StartAug 2012
Primary CompletionMar 2013
TodayJul 2026
First PostedFeb 14, 2012
Enrollment StartAug 1, 2012
Primary CompletionMar 1, 2013
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 14.4 years ago
Interventions
Androxaldrug
oral, capsules, taken one time daily, for 3 months
Placebodrug
Oral capsule taken one time daily for 3 months