The National Institutes of Health (NIH) is conducting a clinical trial to determine whether testosterone supplements can help older men perform better physically, mentally and sexually. The study, called The Testosterone Trial, will include 800 men in 12 U.S. cities, and is designed to help consumers make informed decisions about the risks vs. rewards of testosterone replacement therapy (TRT).
Free Testosterone Lawsuit Evaluation: If you or a loved one has been injured by a testosterone supplement, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer of the testosterone drug and we can help.
What’s the Problem?
As men get older, their serum testosterone concentrations decrease, as do their physical, sexual and cognitive abilities. Additionally, the incidence of cardiovascular disease and diabetes increase over time. Researchers believe the decrease in testosterone levels may be a cause of these functional impairments in older men because young men who have low testosterone levels due to pituitary or testicular disease also experience these impairments. Previous studies to determine whether testosterone supplements could improve these abilities in elderly men reported inconclusive results, possibly because the numbers of test subjects were too small and their testosterone levels prior to treatment were not unequivocally low.
Goal of The Testosterone Trial
The Testosterone Trial is intended to test the hypothesis that “Low T” treatments can improve older men’s physical and sexual function, cognitive abilities, and low hemoglobin concentration, as well as decrease risk factors for cardiovascular disease and type 2 diabetes. The study involves 6 components: Physical Function Trial, Sexual Function Trial, Vitality Trial, Cognitive Function Trial, Anemia Trial and Cardiovascular Trial.
To qualify for The Testosterone Trial, men must:
- Be 65 years or older
- Have serum testosterone levels under 250 ng/dL at 8AM on two occasions
- Have measured functional impairments in walking, libido or vitality
- Be at relatively low risk for prostate cancer
- Not have severe lower urinary tract symptoms
Men who qualify will receive either a testosterone gel or placebo gel for a period of 1 year. Testosterone dosages will be adjusted to keep the serum concentration within the normal range for young men.
Physical function will be assessed by:
- Distance walked in six minutes
- PF10 questionnaire
- Ascertainment of falls
Sexual function will be assessed by:
- The Harbor-UCLA 7-day Sexual Diary
- International Index of Erectile Function
- Derogatis Interview for Sexual Functioning for Men
Vitality will be assessed by:
- The FACIT-Fatigue Scale
- Vitality Scale of the SF-36
- Positive and Negative Affect Scales
- PHQ-9 depression scale
Cognitive function will be assessed by:
- The Wechsler Memory Scale Revised Logical Memory II subscale recall
- Benton Visual Retention Test
- Card Rotation test
- Trail Making Test
Cardiovascular and metabolic risk will be assessed by:
- Blood tests for lipids
- Markers of inflammation
- Vascular function
Anemia will be assessed by hemoglobin concentration.
- Albert Einstein College of Medicine, Bronx, NY
- Baylor College of Medicine, Houston, TX
- Boston Medical Center, Boston, MA
- Northwestern University Feinberg School of Medicine, Chicago, Il
- University of Alabama at Birmingham, Birmingham, AL
- University of California at Los Angeles, Harbor-UCLA Medical Center, Torrance, CA
- University of California at San Diego, La Jolla, CA
- University of Florida, Gainesville, FL
- University of Pittsburgh, Pittsburgh, PA
- University of Minnesota, Minneapolis, MN
- University of Washington, VA Puget Sound Health Care System, Seattle, WA
- Yale School of medicine, New Haven CT
Can I File a Testosterone Lawsuit?
Only a qualified attorney can determine whether you are eligible to file a lawsuit against the manufacturer of a testosterone supplement, which is why we are currently offering free case evaluations. Simply fill out the confidential evaluation form below to contact our law firm now.
Most cases involving pharmaceuticals allege that a drug was sold with design, manufacturing, and/or marketing defects, which typically refers to a company’s failure to warn of a certain side effect. In the case of testosterone replacement therapy (TRT) products, our attorneys suspect that patients may be able to take legal action in light of claims that the supplements’ manufacturers failed to adequately warn doctors and patients about the risk of heart attack and other severe cardiovascular side effects.
How Can Filing a Lawsuit Help Me?
By filing a lawsuit against the maker of a testosterone booster, you may be entitled to collect compensation for all current and future medical expenses related to the treatment of your heart attack or other health problem, as well as for damages for pain and suffering. Additionally, filing a lawsuit can help hold the drug’s manufacturer accountable for releasing an allegedly defective drug into the marketplace, and to discourage other pharmaceutical companies from engaging in similar conduct.
Do I have a Testosterone Lawsuit?
The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Testosterone Lawsuits. We are handling individual litigation nationwide and currently accepting new testosterone injury and death cases in all 50 states.
Free Testosterone Lawsuit Evaluation: Again, if you or a loved one has been injured by a testosterone replacement therapy (TRT) drug, you should contact our law firm immediately. You may be entitled to compensation by filing a Testosterone Suit and we can help.