Status:
COMPLETED
The Cardiac Benefit of Testosterone Replacement in Men With Low Testosterone Levels With Coronary Artery Disease After Successful Intervention of the Blockage or Narrowed Heart Artery
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborating Sponsors:
Abbott
Conditions:
Coronary Artery Disease
Eligibility:
MALE
40-75 years
Phase:
PHASE3
Brief Summary
The purpose of the study is to find out if giving the study drug, Androgel (testosterone) as a testosterone replacement help bring the testosterone to an acceptable level and to find out if it will he...
Detailed Description
Males with coronary heart disease have lower serum levels of bioavailable testosterone than men of a similar age with normal coronary angiograms (English, European Heart Journal, 2000). Low plasma tes...
Eligibility Criteria
Inclusion
- Adult male patients with coronary artery disease (CAD) (one to three vessel diseased).
- Stable cardiac status at least 3 months after percutaneous coronary intervention (PCI).
- No change in cardiac medications for 4 weeks prior to enrollment.
- Testosterone \< 300 ng/dl or free testosterone \< 5.0 ng/dl or bioavailable testosterone \< 150 ng/dl.
- Sex Hormone Binding Globulin (SHBG) \< 7nmol/liter and Free Testosterone \< 50pg/dl
- Prostate Specific Antigen (PSA) \< 2.5 ng/mL or 2.6-3.7ng/mL with a negative prostate biopsy within the last 6 months and pathology report available for investigator's review.
- Subgroup of diabetics with well to moderately controlled diabetes (defined by a HgbA1c of \< 9mg/dL.
Exclusion
- Hematocrit greater than 50%.
- Severe hypertension (exhibit systolic blood pressure \>180mmHg and diastolic blood pressure \>110 mmHg at baseline visit or a have a history of malignant hypertension.
- Significant cardiac arrhythmia (supraventricular tachycardia \[SVT\] or ventricular tachycardia with heart rate exceeding 110 beats per minute at Visit 1).
- ECG abnormalities precluding ST segment analysis on treadmill, or inability to walk on treadmill.
- Poorly controlled, symptomatic, active medical problems (HIV, hepatitis, cancer, benign prostatic hypertrophy, alcohol or drug abuse, major depressive disorder).
- Neurological or psychiatric disorder that would compromise the patient's ability to give informed consent or adhere to the requirements of the protocol.
- History of prostate cancer
- History of hypersensitivity to transdermal testosterone gel.
- International Prostate Symptom Score (IPSS) \>19 at Visit 1.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT00413244
Start Date
January 1 2007
End Date
November 1 2014
Last Update
January 5 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029