NCT01191320

Study to Evaluate the Efficacy of Androxal in Controlling Blood Glucose in Men With Type-2 Diabetes Mellitus

A Study to Evaluate the Efficacy of Androxal® in Improving Glycemic Control in Men With Secondary Hypogonadism or Adult-onset Idiopathic Hypogonadotropic Hypogonadism (AIHH) and Type 2 Diabetes Mellitus With Sub-Optimum Treatment

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Repros Therapeutics Inc. · Industry
• Sex: Male
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Type 2 Diabetes Mellitus
• Secondary Hypogonadism

Interventions

Type	Name	Description
DRUG	Placebo	Placebo capsule 1x daily for 3 months
DRUG	Androxal	Capsules 12.5 mg or 25 mg 1x daily for 3 months

Timeline

• Start date: 2010-10-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2010-08-30
• Last updated: 2014-07-24
• Results posted: 2014-07-24

Locations

18 sites across 1 country: United States