Phase 3
Completed N=51
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
Source: ClinicalTrials.gov NCT00413244 ↗Enrolled (actual)
51
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcomePrimary: Cardiac Stress Test: Time to ST Depression — 439.1; 279.5; 364.0; 292.6 seconds — p=0.03
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cardiac Stress Test: Time to ST Depression |
439.1; 279.5; 364.0; 292.6; 433.0; 342.2 | 0.03 sig |
| PRIMARY Cardiac Stress Testing: Exercise Capacity |
589.7; 452.4; 607.6; 472.1; 614.0; 470.0 | — |
| SECONDARY Seattle Angina Questionnaire (SAQ) |
— | — |
| SECONDARY Reactive Hyperemia Index |
1.96; 1.85; 1.85; 1.81; 1.70; 1.77 | — |
| SECONDARY International Prostate Symptom Score (IPSS) |
— | — |
| SECONDARY Metabolic Equivalents of Task (METS) |
11.0; 9.0; 11.4; 9.0; 11.9; 9.2 | — |
| SECONDARY Aging Male Symptoms (AMS) |
36.5; 35.8; 32.9; 29.8; 36.5; 35.9 | — |
| SECONDARY International Index of Erectile Function (IIEF) |
12.4; 12.2; 14.1; 10.1; 15.7; 14.2 | — |
| SECONDARY IIEF-II Orgasmic Function |
4.8; 4.4; 5.9; 4.2; 5.7; 5.8 | — |
| SECONDARY IIEF -III: Sexual Desire |
5.0; 5.4; 5.6; 4.8; 6.3; 5.6 | — |
| SECONDARY IIEF-IV: Intercourse Satisfaction |
5.5; 5.0; 6.2; 3.6; 6.8; 6.0 | — |
| SECONDARY IIEF-V: Over-all Satisfaction |
4.8; 4.3; 4.9; 3.8; 5.2; 5.2 | — |
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 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.
Data sourced from ClinicalTrials.gov (NCT00413244). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.