NCT02803073

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 16, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

November 21, 2019

Status Verified

November 1, 2019

Enrollment Period

7 months

First QC Date

June 8, 2016

Last Update Submit

November 19, 2019

Conditions

HypogonadismAcute Myocardial Infarction: Rehabilitation Phase

Outcome Measures

Primary Outcomes (1)

  • Metabolic Equivalent

    12 weeks

Secondary Outcomes (1)

  • 6 minute walk test

    12 weeks

Study Arms (2)

Testosterone Replacement

EXPERIMENTAL

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

Drug: Testosterone

Control

PLACEBO COMPARATOR

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

Drug: Normal Saline

Interventions

TestosteroneDRUG

Testosterone Cypionate Intramuscular injections will be administered weekly

Also known as: testosterone cypionate
Testosterone Replacement
Normal SalineDRUG

Normal Saline Intramuscular injections will be administered weekly

Also known as: Saline
Control

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mission Fitness-Medical Center Hospital

Odessa, Texas, 79765, United States

Location

MeSH Terms

Conditions

Hypogonadism

Interventions

Testosteronetestosterone 17 beta-cypionateSaline SolutionSodium Chloride

Condition Hierarchy (Ancestors)

Gonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

AndrostenolsAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsTestosterone CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2016

First Posted

June 16, 2016

Study Start

August 1, 2016

Primary Completion

March 1, 2017

Study Completion

May 1, 2017

Last Updated

November 21, 2019

Record last verified: 2019-11

Locations

US(1)