Effect of Androgel on Type 2 Diabetic Males With Hypogonadism

• Status: Unknown status
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: Male

Summary

This is to study the effect of replacing testosterone on different inflammatory cells in type 2 diabetics with low testosterone levels.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Males with age 35-75 years inclusive.

• Evidence of hypogonadism: low free testosterone.

• Type 2 Diabetes

• People on stable doses of cholesterol lowering medications, blood pressure medications and multi-vitamins are allowed.

• If currently on testosterone replacement,testosterone treatment will be held for 8 weeks.

• BP under control even if on medication.

Exclusion Criteria:

• Coronary event or procedure in previous past 4 wks.

• High PSA

• H/O prostate cancer

• Hepatic or renal disease

• Participation in any other concurrent clinical trial

• Any other life- threatening , non cardiac disease.

• Uncontrolled BP

• Congestive heart failure

• High hemoglobin

• Use of investigational agent or therapeutic regimen within 30 days of study.