The Cardiac Benefit of Testosterone Replacement in Men With Low Testosterone Levels With Coronary… (NCT00413244) | Clinical Trial Compass
CompletedPhase 3
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
United States51 participantsStarted 2007-01
Plain-language 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.
Who can participate
Age range
40 Years – 75 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 adhe…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.