WithdrawnPhase 2/3

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

Stopped: Subjects could not be recruited

United States0Started 2016-08

Plain-language 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.

Who can participate

Age range18 Years

SexMALE

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Inclusion criteria

✓. 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.
✓. Baseline free testosterone levels less than age-specific normal values.
✓. Males 18 years and older

Exclusion criteria

✕. 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.
✕. Current use of testosterone, clomiphene or over the counter testosterone boosters
✕. Patients initiating cardiac rehabilitation 8+ weeks after MI or Non-ST Elevation-Acute Coronary Syndrome
✕. Congestive heart failure, New York Heart Association class IV
✕. Life expectancy less than 1 year,
✕. Baseline hematocrit of \>50%
✕. Allergic reactions to testosterone or testosterone vehicle (i.e. cotton seed oil, etc.)
✕. Physical inability to participate in rehabilitation program (examples: severe claudication, massive obesity, etc.)

What they're measuring

Metabolic Equivalent

Timeframe: 12 weeks

Trial details

NCT IDNCT02803073

SponsorTexas Tech University Health Sciences Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-03

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