Testosterone Replacement in Older Men and Atherosclerosis Progression

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Boston University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Solvay Pharmaceuticals
Information provided by (Responsible Party):
Boston University
ClinicalTrials.gov Identifier:
NCT00287586
First received: February 6, 2006
Last updated: March 6, 2012
Last verified: March 2012
  Purpose

As men grow older, their testosterone levels decrease with age. One-third of men, 70 years of age or older, have low testosterone levels. It is known that short-term testosterone replacement is safe, and can increase muscle strength and physical function, but the risks of long-term testosterone replacement in older men with low testosterone levels are incompletely understood.

Atherosclerosis is characterized by thickening of the artery walls, and the narrowing of the blood vessels as cholesterol is deposited in the lining of the arteries. It is the major cause of cardiovascular disease including ischemic heart disease (heart attacks) and stroke. Although, historically, there has been a widespread perception that higher levels of testosterone might increase the risk of atherosclerosis, the evidence from research does not support this. In observational studies, higher testosterone levels have been correlated with more favorable cardiovascular risk factors, and supplementation with testosterone to bring older men into the normal range for healthy younger men appears to improve several cardiovascular risk factors, and may slow the progression of atherosclerosis.

The primary purpose of this study is to look at the effects of testosterone replacement on the progression of atherosclerosis in older men. This study is also being done to find out whether replacement with testosterone in older men with low testosterone levels improves their health-related quality of life.


Condition Intervention Phase
Hypogonadism
Atherosclerosis
Drug: Testosterone Gel (Androgel)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Testosterone Replacement on Atherosclerosis Progression in Older Men With Low Testosterone Levels

Resource links provided by NLM:


Further study details as provided by Boston University:

Primary Outcome Measures:
  • Atherosclerosis progression as assessed by Cardiac CT and Carotid IMT [ Time Frame: Three years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in Lipid Profiles [ Time Frame: Three years ] [ Designated as safety issue: No ]
  • Changes in Biomarkers of Inflammation [ Time Frame: Three years ] [ Designated as safety issue: No ]
  • Changes in Blood Pressure [ Time Frame: Three years ] [ Designated as safety issue: No ]
  • Changes in Cognitive Function [ Time Frame: Three years ] [ Designated as safety issue: No ]
  • Changes in Muscle Strength [ Time Frame: Three years ] [ Designated as safety issue: No ]
  • Changes in Physical Function [ Time Frame: Three years ] [ Designated as safety issue: No ]

Estimated Enrollment: 360
Study Start Date: March 2003
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Testosterone Gel (Androgel)

    The subjects will receive either 7.5 g testosterone gel to achieve a nominal delivery of 75 mg testosterone daily or placebo gel. Dose adjustments will be made by an unblinded observer.

    This will be implemented as follows: Serum testosterone level measured on treatment day 15 will measured in a sample sent separately to the laboratory such that the result will be reported directly to unblinded physician, who will then communicate the decision about dose adjustment (or not) directly to the research pharmacist through e-mail.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 60 years or greater
  • Hypogonadism, Testosterone 100-400 ng/dl or Free Testosterone < 50 pg/ml
  • Generally good health
  • At least 8 years of primary school education
  • Able to pass screening test for dementia
  • Able to give informed consent

Exclusion Criteria:

  • Testosterone level < 100 ng/dl (these individuals will be referred for evaluation of severe hypogonadism)
  • Use of testosterone or other androgens (DHEA, Androstenedione)in last year
  • Use of growth hormone in the last year
  • Current alcohol of drug dependence (AUDIT Score > 8)
  • Diseases known to affect gonadal function
  • Medications known to affect gonadal function eg. Anticonvulsants, Glucocorticoids such as prednisone
  • Prostate cancer, Breast cancer
  • Any cancer that may limit life expectancy to less than 5 years
  • Limiting neuromuscular, joint or bone disease
  • History of stroke with residual neurologic deficit
  • Neurologic condition that would impair cognitive function including:

epilepsy, multiple sclerosis, HIV, Parkinson's disease, stroke

  • Psychiatric disorder in the last year meeting DSMIV Axis 1 criteria
  • Use of psychotropic medicine for at least 6 months
  • Dementia as assessed by (Telephone Interview for Cognitive Status modified score less than 31)
  • Severe symptoms of BPH (American Urological Association symptom index score greater than 21)
  • Prostate nodule or induration of digital rectal exam (DRE)
  • Prostate specific antigen (PSA) greater than 4 unless participant has had a negative transrectal biopsy within last 3 months
  • Limiting heart disease in including NY Class III or IV - congestive heart failure, unstable angina, or myocardial infarction (MI) in last 3 months
  • Liver function tests (AST and ALT) greater than 3 times the upper limit of the reference range
  • Serum Cr greater than 2.5 mg/dl
  • Hematocrit greater than 48%
  • Hemoglobin (Hb)A1c greater than 9.0%
  • Untreated thyroid disease
  • Uncontrolled hypertension (systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg)
  • Body mass index (BMI greater than 35 kg/m2)
  • Untreated severe obstructive sleep apnea
  • Development of EKG changes consistent with myocardial ischemia or changes in blood pressure during cardiopulmonary exercise testing will be excluded from testing of muscle strength and physical function.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00287586

Locations
United States, Arizona
Kronos Longevity Research Institute
Phoenix, Arizona, United States, 85016
United States, California
Charles R. Drew University of Medicine and Science
Los Angeles, California, United States, 90059
United States, Massachusetts
Boston University / Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston University
Solvay Pharmaceuticals
Investigators
Principal Investigator: Shalender Bhasin, MD Boston University / Boston Medical Center, Boston, MA
  More Information

No publications provided

Responsible Party: Boston University
ClinicalTrials.gov Identifier: NCT00287586     History of Changes
Other Study ID Numbers: H-24192
Study First Received: February 6, 2006
Last Updated: March 6, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Boston University:
Testosterone Replacement
Heart Disease
Vascular Disease
Risk Factors for Cardiovascular Disease
Cholesterol
Obesity
Blood pressure
Quality of Life

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Hypogonadism
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Gonadal Disorders
Endocrine System Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on October 19, 2014