drugset / Trial / NCT01993225

A Randomized, Double Blind, Placebo-Controlled, Multi-Center Phase III Study in Men With Acquired Hypogonadotropic Hypogonadism to Compare Changes in Testosterone and Sperm Concentration Following Treatment With 12.5 mg or 25 mg Androxal or AndroGel 1.62%

NCT01993225

Phase 3 Completed 120 enrolled Repros Therapeutics Inc.
RandomizedParallel-groupDouble-blindTreatment

Summary

This is a Randomized, Double Blind, Placebo-Controlled, Multi-Center Phase III Study in Men with Acquired Hypogonadotropic Hypogonadism to Compare Changes in Testosterone and Sperm Concentration Following Treatment with 12.5 mg or 25 mg Androxal or AndroGel 1.62%.

Timeline

Start
2014-01
Primary completion
2014-08
Completion
2014-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Androxal Unknown 12.5 mg
Subject Androxal Unknown 25 mg
Comparator Testosterone Small molecule 1.62 %