Efficacy and Safety of Androgel in the Treatment of Hypogonadal and Low Testosterone Men With Type 2 Diabetes

Phase 2

Completed

• Conditions: Hypogonadism; Type 2 Diabetes

• Registration Number: NCT00141492
• Lead Sponsor: Solvay Pharmaceuticals

Brief Summary

This study is to investigate how well Androgel, when tested against placebo gel, helps to control blood sugar levels in males with type 2 diabetes who have low testosterone (the main male hormone) blood levels and are taking oral diabetic medicines alone or in combination with insulin.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2005-08-30
• Study First Submitted QC: 2005-08-30
• Study First Posted: 2005-09-01
• Primary Completion: 2007-06
• Study Completion: 2007-06
• Status Verified: 2009-01
• Last Update Submitted: 2015-01-19
• Last Update Posted: 2015-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

1. Able to read and write
2. Males
3. Between 30-80 years old
4. Have type 2 diabetes
5. Diagnoses of hypogonadism or low testosterone

Exclusion Criteria

1. On insulin monotherapy
2. Use of testosterone therapy within the last 6 months
3. Male breast cancer
4. History of prostate cancer
5. History of clinically significant sleep apnea

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (70)

Site 58; 🇺🇸 Birmingham, Alabama, United States

Site 67; 🇺🇸 Calera, Alabama, United States

Site 54; 🇺🇸 Mobile, Alabama, United States

Site 16; 🇺🇸 Phoenix, Arizona, United States

Site 35; 🇺🇸 Anaheim, California, United States

Site 23; 🇺🇸 Concord, California, United States

Site 55; 🇺🇸 La Jolla, California, United States

Site 8; 🇺🇸 Los Gatos, California, United States

Site 12; 🇺🇸 Mission Viejo, California, United States

Site 1; 🇺🇸 Torrance, California, United States

Scroll for more (60 remaining)