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| Sponsor: | Boston University |
|---|---|
| Collaborator: |
Solvay Pharmaceuticals |
| Information provided by: | Boston University |
| ClinicalTrials.gov Identifier: | NCT00287586 |
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 IV |
| 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 |
| Estimated Enrollment: | 360 |
| Study Start Date: | March 2003 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
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 |
Inclusion Criteria:
Exclusion Criteria:
epilepsy, multiple sclerosis, HIV, Parkinson's disease, stroke
Contacts and 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 | |
| Principal Investigator: | Shalender Bhasin, MD | Boston University / Boston Medical Center, Boston, MA |
More Information
| Responsible Party: | Shalender Bhasin, MD, Chief of Endocrinology Department at Boston University Medical Center, BUMC |
| ClinicalTrials.gov Identifier: | NCT00287586 History of Changes |
| Other Study ID Numbers: | H-24192 |
| Study First Received: | February 6, 2006 |
| Last Updated: | January 29, 2009 |
| Health Authority: | United States: Food and Drug Administration |
|
Testosterone Replacement Heart Disease Vascular Disease Risk Factors for Cardiovascular Disease |
Cholesterol Obesity Blood pressure Quality of Life |
|
Atherosclerosis Hypogonadism Arteriosclerosis 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 |
