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

Texas Tech University Health Sciences Center

Status and phase: Withdrawn; Phase 3; Phase 2

Conditions: Hypogonadism; Acute Myocardial Infarction: Rehabilitation Phase

Treatments: Drug: Testosterone; Drug: Normal Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT02803073

L16-116

Details and patient eligibility

About

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.

Full description

Testosterone deficiency can decrease muscle strength. The researchers will replace testosterone in hypogonadal men undergoing rehabilitation exercises after heart attack.

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

Testosterone Replacement

Experimental group

Description:

The experimental group will receive 0.5 ml (100 mg) testosterone cypionate Intramuscular injections each week for 11 weeks.

Treatment:

Drug: Testosterone

Control

Placebo Comparator group

Description:

Patients in the control group will receive intramuscular normal saline injections.

Treatment:

Drug: Normal Saline