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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Hypogonadism; Acute Myocardial Infarction: Rehabilitation Phase
• Intervention / Treatment: Drug: Testosterone; Drug: Normal Saline

Detailed Description

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

• Study Type: Interventional
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Texas
    • Odessa, Texas, United States, 79765
      • Mission Fitness-Medical Center Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Metabolic Equivalent	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
6 minute walk test	12 weeks

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: June 8, 2016
• First Submitted That Met QC Criteria: June 15, 2016
• First Posted (Estimate): June 16, 2016

Study Record Updates

• Last Update Posted (Actual): November 21, 2019
• Last Update Submitted That Met QC Criteria: November 19, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Endocrine System Diseases; Gonadal Disorders; Myocardial Infarction; Infarction; Hypogonadism; Physiological Effects of Drugs; Antineoplastic Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Androgens; Anabolic Agents; Testosterone; Methyltestosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
• Other Study ID Numbers: L16-116

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED