Effect of Androgel on Type 2 Diabetic Males With Hypogonadism

Completed · Phase 4 · Has a placebo group

Conditions studied: Diabetes Mellitus Type 2

In brief

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

Key facts

Study ID

NCT00350701

Run by

University at Buffalo

People needed

49

Starts

2006-07-01

Expected to finish

2013-07-01

Last updated by the study team

2022-02-10

Who can join

Age: 35 and older, up to 75. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Diabetes-Endocrinology Center of Western NY, 115 flint road — Buffalo, New York, United States

Full record on ClinicalTrials.gov

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