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
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Intervention: AndroGel 5 Grams; Placebo
Intervention description: Placebo (randomization will occur on a 2:1 drug to placebo). A total of 50 subjects will be randomized to receive Androgel 5 grams and 25 subjects will be randomized to receive placebo.
Androgel treatment/Placebo (after the treatment arm is assigned, subjects will be instructed to begin the study drug at 1 week post entry into the study and will continue to take the study drug for a total of 6 months. The study drug has to be applied to the skin once daily for 6 months.; Placebo (randomization will occur on a 2:1 drug to placebo). A total of 50 subjects will be randomized to receive Androgel 5 grams and 25 subjects will be randomized to receive placebo.
Androgel treatment/Placebo (after the treatment arm is assigned, subjects will be instructed to begin the study drug at 1 week post entry into the study and will continue to take the study drug for a total of 6 months. The study drug has to be applied to the skin once daily for 6 months.
Intervention MeSH terms: Testosterone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 51.0
Sex: Male
Minimum age: 40 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Hypogonadal; coronary artery disease; percutaneous coronary intervention (PCI)

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 help improve heart condition in males with coronary artery disease (CAD) following
      successful percutaneous coronary intervention.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 Criteria:

          -  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.