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

Sponsor

Texas Tech University Health Sciences Center (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02803073

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hypogonadism Acute Myocardial Infarction: Rehabilitation Phase	Drug: Testosterone Drug: Normal Saline	Phase 2/Phase 3

Detailed Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 1, 2016

Actual Primary Completion Date :

Mar 1, 2017

Actual Study Completion Date :

May 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Testosterone Replacement The experimental group will receive 0.5 ml (100 mg) testosterone cypionate Intramuscular injections each week for 11 weeks.	Drug: Testosterone Testosterone Cypionate Intramuscular injections will be administered weekly Other Names: testosterone cypionate
Placebo Comparator: Control Patients in the control group will receive intramuscular normal saline injections.	Drug: Normal Saline Normal Saline Intramuscular injections will be administered weekly Other Names: Saline

Arm

Intervention/Treatment

Experimental: Testosterone Replacement

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

Drug: Testosterone

Testosterone Cypionate Intramuscular injections will be administered weekly

Other Names:

testosterone cypionate

Placebo Comparator: Control

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

Drug: Normal Saline

Normal Saline Intramuscular injections will be administered weekly

Other Names:

Saline

Outcome Measures

Primary Outcome Measures

Metabolic Equivalent [12 weeks]

Secondary Outcome Measures

6 minute walk test [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mission Fitness-Medical Center Hospital	Odessa	Texas	United States	79765

Sponsors and Collaborators

Texas Tech University Health Sciences Center

Investigators

Principal Investigator: Osama Mukarram, MD, Texas Tech University Health Sciences Center
Principal Investigator: Craig W Spellman, DO, Texas Tech University Health Sciences Center
Principal Investigator: Sandeep Dhindsa, MD, Texas Tech University Health Sciences Center