At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 17 enrolled
Drug / intervention
25 mg Androxal +1 moredrug
Likely dose
25 mg Androxalfrom 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, Open-Label, Fixed Dose, Active-Control, Multi-Center Phase IIB Study to Evaluate Fertility in Men With Secondary Hypogonadism, Comparing Androxal® to a Topical Testosterone in Men Previously Treated With Topical Testosterone.
In Brief
A Phase 2 clinical trial evaluating 25 mg Androxal and Testim 1% for Secondary Hypogonadism. Completed, enrolled 17 participants across 2 sites.
Detailed Summary
The study was designed to determine if Androxal® would affect sperm parameters (count, concentration, volume) in men with secondary hypogonadism who have been previously treated with topical testosterone.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSecondary Hypogonadism
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2008
First PostedJun 2008
Primary CompletionJul 2009
Study CompletionAug 2009
TodayJul 2026
First PostedJun 27, 2008
Enrollment StartJun 1, 2008
Primary CompletionJul 1, 2009
Study CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 18.0 years ago
Interventions
25 mg Androxaldrug
25 mg Androxal capsules, 1 capsule daily for 6 months
Testim 1%drug
Testim 1% gel, dosage to be titrated according to manufacturer's instructions, once daily for 6 months