A Study of the Efficacy of Using Testosterone in Older Men
Information source: University of Pennsylvania
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Andropause
Intervention: AndroGel® (testosterone gel) (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: University of Pennsylvania Official(s) and/or principal investigator(s):
Peter J Snyder, MD, Principal Investigator, Affiliation: University of Pennsylvania
Overall contact:
Denise Cifelli, MS, Phone: 215-573-4534, Email: cifelli@mail.med.upenn.edu
Summary
The Testosterone Trials are a multi-center set of trials involving 12 clinical sites
geographically distributed across the United States.
The primary specific aims are to test the hypotheses that testosterone treatment of elderly
men whose serum testosterone concentrations are unequivocally low - and who have symptoms
and objectively measured abnormalities in at least one of five areas that could be due to
low testosterone (physical or sexual function, vitality, cognition, and anemia) - will
result in more favorable changes in those abnormalities than placebo treatment.
Clinical Details
Official title: Randomized, Placebo-Controlled, Double-Blind Study of Five Coordinated Testosterone Treatment Trials in Older Men
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: To test the hypothesis that testosterone treatment for one year compared to placebo will be associated with improved walking speed, improvement in sexual activity, improvement on the vitality scale and verbal memory test, and anemia correction.
Detailed description:
As men get older, they experience many conditions, often together, that eventually result in
the inability to perform many activities of daily living, an increased propensity to fall,
and decreased independence. These conditions include mobility disability and low vitality.
Elderly men also experience increased anemia, metabolic syndrome, decreased sexual function
and memory impairment. These conditions likely have multiple causes, but one cause that
could contribute to all of them is a low serum testosterone concentration. When young
hypogonadal men are treated with testosterone, they experience improvements in sexual
function, muscle mass and strength, bone mineral density, sense of well being, and anemia.
However, the benefits of testosterone therapy in older men with age-related decline in
testosterone concentration are not known and are the subject of this investigation.
Eligibility
Minimum age: 65 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Men greater than or equal to 65 years old
- Total serum testosterone concentration ≥100 and ≤250 ng/dL at 8 -10 AM at each of two
screening visits
Exclusion Criteria:
- Diagnosed prostate cancer or prostatic intraepithelial neoplasia (PIN) or, by the
Prostate Cancer Risk Calculator, a >30% risk of having overall prostate cancer or >7%
risk of having high grade prostate cancer
- Severe lower urinary tract symptoms (score of ≥ 19) by the International Prostate
Symptom Score questionnaire
- Hemoglobin <10 g/dL or >16. 0 g/dL
- Sleep apnea, diagnosed but untreated
- Alcohol or substance abuse within the past year (based on self report)
- Angina not controlled by treatment, NYHA class III or IV congestive heart failure, or
myocardial infarction within 3 months before entry
- Severe pulmonary disease that precludes physical function tests
- Serum creatinine >2. 5 mg/dL; ALT 3x upper limit of normal; hemoglobin A1c >9%
- Breast and lung cancer, and cancers that limit life expectancy to <5 years, or which
require current therapy
- Body mass index (BMI) >35 kg/m2
- Testosterone level <100 ng/dL
- Mini Mental State Exam (MMSE) Score <24
- Untreated moderate or severe depression as defined by a score of >14 on the PHQ-9
questionnaire. Subjects with depression who have been on stable anti-depressant
medication for more than three months are eligible.
- Severe major depression as defined by a PHQ-9 score >14 or other Axis I psychiatric
disorder such as schizophrenia and bipolar disease (308)
- Use of the following medications within the previous three months:
- drugs that affect serum testosterone concentration
- rhGH or megesterol acetate
- introduction of anti-depressant medication
- daily use of prednisone for more than two weeks
- Antipsychotic medications for Axis I disorders
- Opiate abuse within the past six months
- Skin conditions at the testosterone gel application site, such as ulcer, erosion,
lichenification, inflammation, or crust, or generalized skin conditions such as
psoriasis or eczema that might affect testosterone absorption or tolerability of the
testosterone gel
- Known skin intolerance to alcohol or allergy to any of the ingredients of
testosterone gel
Locations and Contacts
Denise Cifelli, MS, Phone: 215-573-4534, Email: cifelli@mail.med.upenn.edu
University of Alabama at Birmingham, Birmingham, Alabama 35294, United States
University of California San Diego, La Jolla, California 92093, United States
University of California at Los Angeles, Torrance, California 90501, United States
Yale University, New Haven, Connecticut 06520, United States
University of Florida, Gainesville, Florida 32611, United States
Northwestern University, Chicago, Illinois 60208, United States
Boston University, Boston, Massachusetts 02215, United States
University of Minnesota, Minneapolis, Minnesota 55455, United States
Albert Einstein College of Medicine, Bronx, New York 10461, United States
University of Pittsburgh, Pittsburgh, Pennsylvania 15261, United States
Baylor College of Medicine, Houston, Texas 76798, United States
Seattle VA Medical Center, Seattle, Washington 98108, United States
Additional Information
Starting date: August 2009
Ending date: January 2015
Last updated: May 15, 2009
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