Effect of Testosterone Replacement on Exercise Capacity in Hypogonadal Men After a Recent Myocardial Infarction

• Status: Withdrawn
• Trial end date: 2017-05-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to determine the effects of testosterone replacement in hypogonadal men on exercise tolerance and cardiac rehabilitation after an acute myocardial infarction.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Texas Tech University Health Sciences Center
• Treatments: Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

Inclusion Criteria:

1. All men status-post Myocardial Infarction or Non-ST Elevation-Acute Coronary Syndrome within the last 3-8 weeks enrolling in the cardiac rehabilitation program at Mission Fitness-Medical Center Hospital.

2. Baseline free testosterone levels less than age-specific normal values.

3. Males 18 years and older

Exclusion Criteria:

1. Prostate Specific Antigen greater than age based, ethnic-specific cut points (see Appendix), history of metastatic prostate cancer or symptoms suggestive of severe Benign Prostatic Enlargement.

2. Current use of testosterone, clomiphene or over the counter testosterone boosters

3. Patients initiating cardiac rehabilitation 8+ weeks after MI or Non-ST Elevation-Acute Coronary Syndrome

4. Congestive heart failure, New York Heart Association class IV

5. Life expectancy less than 1 year,

6. Baseline hematocrit of >50%

7. Allergic reactions to testosterone or testosterone vehicle (i.e. cotton seed oil, etc.)

8. Physical inability to participate in rehabilitation program (examples: severe claudication, massive obesity, etc.)

9. Participation in any other concurrent clinical trial, use of an investigational agent or therapeutic regimen within 30 days of study

10. Patients formerly diagnosed with obstructive sleep apnea.

11. Patients using opiate analgesics

12. Patients with aspartate aminotransferase/alanine aminotransferase values more than 3 times normal

13. History of Deep venous thrombosis