Official Title: “Randomized, Placebo-controlled, Double-blind Study of Five Coordinated Testosterone Treatment Trials in Older Men”

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.

Study Type: Interventional

Study Design: Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Study Primary Completion Date: November 2014

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.

Intervention(s) in this Clinical Trial

• Drug: AndroGel® (testosterone gel)
  • AndroGel or placebo is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Testosterone gel
• Placebo Comparator: Placebo gel

Primary Measures

• 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.
  • Time Frame: One year.
    Safety Issue?: No

Inclusion Criteria:

• Men greater than or equal to 65 years old
• Total serum testosterone concentration ≥100 and ≤250 ng/dL at 7 -10 AM at each of two screening visits

Exclusion Criteria:

• Diagnosed prostate cancer, prostatic intraepithelial neoplasia (PIN), prostate nodule 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
• Myocardial infarction within the previous 3 months before entry
• Stroke within the previous 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 >8.5%
• 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, or other Axis I psychiatric disorders, such as schizophrenia. Subjects with depression who have been stable for more than three months while taking an antidepressant medication are eligible.
• 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

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 65 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: University of Pennsylvania

Overall Clinical Trial Officials and Contacts

Peter J Snyder, MD Principal Investigator University of Pennsylvania  

Overall Contact: Denise Cifelli, MS 215-573-4534 cifelli@mail.med.upenn.edu

Information obtained from ClinicalTrials.gov on September 02, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00799617

Study ID Number: U01 AG030644

ClinicalTrials.gov Identifier: NCT00799617

Health Authority: United States: Food and Drug Administration