drugset / Trial / NCT01993212

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%

NCT01993212

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 the 12.5 mg or 25 mg Androxal or AndroGel 1.62%.

Timeline

Start
2014-01
Primary completion
2014-09
Completion
2014-09

Drugs

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