A Phase III, Randomized, Double-Blind, Placebo-Controlled, Open-Label, Active-Controlled Study to Evaluate the Safety and Efficacy of Androxal™ Treatment in Men With Secondary Hypogonadism.
Phase of Trial: Phase III
Latest Information Update: 01 Sep 2014
At a glance
- Drugs Enclomifene; Testosterone
- Indications Hypogonadism
- Focus Therapeutic Use
- Sponsors Repros Therapeutics
- 29 Dec 2010 A reanalysis of trial data by an independent statistician has shown emclomifene provides significant improvement in testosterone levels in men with testosterone levels of less than or equal to 250 ng/dL, according to a Repros Therapeutics media release.
- 10 Nov 2010 In preparation for phase 3 trials, Repros Therapeutics agreed with Type B meeting FDA comments and will analyse the ZA-003 study for the subset of men with morning testosterone less than 250 ng/dl and submit data.
- 18 Aug 2010 Repros Therapeutics has requested a Type B Meeting with the FDA to review the company's phase III protocols for Androxal in the treatment of secondary hypogonadism, according to a Repros Therapeutics media release.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History