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

• Status: Completed
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Solvay Pharmaceuticals
• Treatments: Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

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