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

Primary Purpose

Hypogonadism, Acute Myocardial Infarction: Rehabilitation Phase

Status

Withdrawn

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Testosterone

Normal Saline

About this trial

This is an interventional treatment trial for Hypogonadism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Mission Fitness-Medical Center Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Testosterone Replacement

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

Metabolic Equivalent

Secondary Outcome Measures

6 minute walk test

Full Information

NCT ID

NCT02803073

First Posted

June 8, 2016

Last Updated

November 19, 2019

Sponsor

Texas Tech University Health Sciences Center

1. Study Identification

Unique Protocol Identification Number

NCT02803073

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Withdrawn

Why Stopped

Subjects could not be recruited

Study Start Date

August 2016 (Actual)

Primary Completion Date

March 2017 (Actual)

Study Completion Date

May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Texas Tech University Health Sciences Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypogonadism, Acute Myocardial Infarction: Rehabilitation Phase

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Testosterone Replacement

Arm Type

Experimental

Arm Description

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

Arm Title

Control

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Testosterone

Other Intervention Name(s)

testosterone cypionate

Intervention Description

Testosterone Cypionate Intramuscular injections will be administered weekly

Intervention Type

Drug

Intervention Name(s)

Normal Saline

Other Intervention Name(s)

Saline

Intervention Description

Normal Saline Intramuscular injections will be administered weekly

Primary Outcome Measure Information:

Title

Metabolic Equivalent

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

6 minute walk test

Time Frame

12 weeks

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Osama Mukarram, MD

Organizational Affiliation

Texas Tech University Health Sciences Center

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Craig W Spellman, DO

Organizational Affiliation

Texas Tech University Health Sciences Center

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Sandeep Dhindsa, MD

Organizational Affiliation

Texas Tech University Health Sciences Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mission Fitness-Medical Center Hospital

City

Odessa

State/Province

Texas

ZIP/Postal Code

79765

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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