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Testosterone Replacement and Exercise Capacity in Hypogonadal Men

June 11, 2019

Overview

 

This study examines the effect of testosterone replacement on the ability to exercise for men with functional competence of the gonads after a recent heart attack.

 

Study Information

 

This is a randomized, interventional double-blind, parallel assignment with an estimated 60 participants. The study began in August 2016 and is estimated to be completed by  December 2019.

 

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.)
  • Participation in any other concurrent clinical trial, use of an investigational agent or therapeutic regimen within 30 days of study
  • Patients formerly diagnosed with obstructive sleep apnea.
  • Patients using opiate analgesics
  • Patients with aspartate aminotransferase/alanine aminotransferase values more than 3 times normal
  • History of Deep venous thrombosis

 

Location

 

You may participate in this clinical trial at Mission Fitness-Medical Center Hospital in Odessa, Texas, United States, 79765. If you have any questions or concerns, contact Ryan Baldomero, DNP at 432-640-1472 or at RBaldomero@echd.org.

 

Sponsors/Collaborators

 

This study is sponsored by Texas Tech University Health Sciences Center with Osama Mukkaram, MD, Craig W Spellman, DO, and Sandeep Dhindsa, MD as the Principal Investigators.

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