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Clinical Trial Summary

The purpose of this study is to determine the effect the investigative drug has on glycemic control in men with type 2 diabetes mellitus (T2DM) and secondary hypogonadism


Clinical Trial Description

A phase IIB, multi-center, randomized, parallel, placebo- and active-controlled trial in adult male subjects with secondary hypogonadism who have been treated with OHAs but are not in glycemic control. All subjects currently treated with exogenous testosterone will discontinue at screening for at least 21 days and remain off testosterone for the course of the study. One hundred twenty to 150 subjects will be randomly assigned to one of three treatment groups according to a 1:1:1 ratio. Subjects will receive one of two dose strengths of Androxal or placebo in addition to their usual dose of mono- or combination OHAs for three months. Following an initial screening period, subjects will return monthly for 3 months and 1 month later for a follow-up visit. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01191320
Study type Interventional
Source Repros Therapeutics Inc.
Contact
Status Completed
Phase Phase 2
Start date October 2010
Completion date December 2011

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