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

Hypogonadism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02803073
• Other study ID #: L16-116
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• Start date: August 2016
• Est. completion date: May 2017

Study information

• Verified date: November 2019
• Source: Texas Tech University Health Sciences Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Myocardial Infarction: Rehabilitation Phase
• Hypogonadism
• Infarction
• Myocardial Infarction

Intervention

Drug:
• Testosterone
Testosterone Cypionate Intramuscular injections will be administered weekly
• Normal Saline
Normal Saline Intramuscular injections will be administered weekly

Locations

Country	Name	City	State
United States	Mission Fitness-Medical Center Hospital	Odessa	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Tech University Health Sciences Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolic Equivalent		12 weeks
Secondary	6 minute walk test		12 weeks