drugset / Trial / NCT01386606

The Effect on Androxal Versus Androgel on Morning Testosterone in Men With Secondary Hypogonadism (Low Testosterone)

NCT01386606 ↗

Phase 2 Completed 60 enrolled Repros Therapeutics Inc.
RandomizedParallel-groupSingle-blindTreatment

Summary

The study will determine the effects of three doses of Androxal(enclomiphene citrate)on morning testosterone versus AndroGel(approved topical treatment)in men with low testosterone (\<350 ng/dL)after 6 weeks of continuous dosing.

Timeline

Start
2011-06
Primary completion
2011-10
Completion
2011-10

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Androxal 6.25 mg vs Androxal 12.5 mg vs Androxal 25 mg vs AndroGel; p = 0.056; Regression, Linear; note: P-value of treatment group. NCT01386606 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Androxal Unknown 6.25 mg Oral
Subject Androxal Unknown 12.5 mg Oral
Subject Androxal Unknown 25 mg Oral
Comparator Testosterone Small molecule 5 g Topical