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

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ClinicalTrials.gov Identifier: NCT02803073
Recruitment Status : Withdrawn (Subjects could not be recruited)
First Posted : June 16, 2016
Last Update Posted : November 21, 2019
Sponsor:
Information provided by (Responsible Party):
Texas Tech University Health Sciences Center

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.

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Study Type : Interventional  (Clinical Trial)
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 : August 2016
Actual Primary Completion Date : March 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Saline




Primary Outcome Measures :
  1. Metabolic Equivalent [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. 6 minute walk test [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02803073


Locations
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United States, Texas
Mission Fitness-Medical Center Hospital
Odessa, Texas, United States, 79765
Sponsors and Collaborators
Texas Tech University Health Sciences Center
Investigators
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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

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Responsible Party: Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier: NCT02803073     History of Changes
Other Study ID Numbers: L16-116
First Posted: June 16, 2016    Key Record Dates
Last Update Posted: November 21, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Myocardial Infarction
Hypogonadism
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Gonadal Disorders
Endocrine System Diseases
Methyltestosterone
Testosterone
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents