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NCT00287586 · ClinicalTrials.gov registry record · Phase 4
Testosterone Replacement in Older Men and Atherosclerosis Progression
A Phase 4 study of Atherosclerosis and Hypogonadism, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 308
- Enrollment target
- 3
- Study locations
NCT00287586: Completed Phase 4 study of Atherosclerosis and Hypogonadism, sponsored by Brigham and Women's Hospital.
NCT00287586 is a Phase 4 study of Atherosclerosis and Hypogonadism that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 308 participants, below the 1,061-participant average among 69 other Atherosclerosis trials with a reported enrollment target (71% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00287586, a Phase 4 study of Atherosclerosis and Hypogonadism, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 308 participants
- Enrollment target
- 3
- Study locations
Study Summary
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.
Primary Outcome
B-mode carotid artery images for IMT were acquired from the far wall of the distal centimeter of the right carotid artery with high-resolution ultrasound equipment. IMT is used as a predictor of the incidence of cardiovascular events. An increase in the IMT thickness is associated with a higher incidence of cardiovascular events. Less thickening is best. Change is expressed in millimeters (mm).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Testosterone Gel (Androgel)
Study Locations (3)
Arizona
- Kronos Longevity Research Institute - Phoenix
California
- Charles R. Drew University of Medicine and Science - Los Angeles
Massachusetts
- Boston University / Boston Medical Center - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 308 participants |
| Start Date | 2004-09 |
| Est. Completion | 2012-05-12 |
| Phase | Phase 4 |
What the finished NCT00287586 record still lists
NCT00287586 is an interventional study that assigns participants to a tested intervention. The registered 308 participants enrollment target is mid-sized for trials with a published cap, below the 1,061-participant average among 69 other Atherosclerosis trials with a reported enrollment target (71% lower).
The record links to 2 conditions, with Atherosclerosis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00287586 reports a single indexed study location in Arizona, California, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT00287586 about?
NCT00287586 is a clinical study titled "Testosterone Replacement in Older Men and Atherosclerosis Progression". 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 repl...
What is the current status of trial NCT00287586?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 308 participants. The study started on 2004-09. Estimated completion is 2012-05-12.
What conditions does trial NCT00287586 study?
This clinical trial studies the following conditions: Atherosclerosis, Hypogonadism.
What interventions are being tested in trial NCT00287586?
The interventions under investigation include: Placebo (DRUG), Testosterone Gel (Androgel) (DRUG).
Who is sponsoring clinical trial NCT00287586?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00287586 being conducted?
This trial has 3 study locations across Arizona, California, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Atherosclerosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00287586's enrollment target sits among peer trials
308 27th of 69 higher than 43 of 69 other Atherosclerosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Atherosclerosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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