drugset / Trial / NCT02160704

Androxal in Male Infertility

NCT02160704

Phase 2/3 Withdrawn Baylor College of Medicine
RandomizedParallel-groupDouble-blindTreatment

Summary

This is an exploratory, single center, randomized, parallel, double-blind placebo- and active-controlled trial in adult males ages 18 to 35 years of age who have male infertility of unknown cause. Approximately 50 men will be randomly assigned to one of two treatment groups according to a 1:1 ratio. About half of the men will receive 25mg Androxal and half of the men will receive a placebo (non-active pill) for 16 weeks. This study will last approximately 4 months and involve up to 7 visits. The purpose of this study is to determine the effect the Androxal on sperm production.

Timeline

Start
2014-09-22
Primary completion
2016-08-02
Completion
2016-08-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Androxal Unknown 25 mg

Indications