A Study of the Efficacy of Using Testosterone in Older Men - Full Text View

Sponsors and Collaborators:	University of Pennsylvania Solvay Pharmaceuticals
Information provided by:	University of Pennsylvania
ClinicalTrials.gov Identifier:	NCT00799617

Purpose

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.

Condition	Intervention	Phase
Andropause	Drug: AndroGel® (testosterone gel)	Phase III

MedlinePlus related topics: Anemia Memory

Drug Information available for: Testosterone Methyltestosterone Oxymesterone Testosterone enanthate Testosterone Propionate Testosterone undecanoate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Randomized, Placebo-Controlled, Double-Blind Study of Five Coordinated Testosterone Treatment Trials in Older Men

Further study details as provided by University of Pennsylvania:

Primary Outcome 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. ] [ Designated as safety issue: No ]

Estimated Enrollment:	800
Study Start Date:	January 2009
Estimated Study Completion Date:	January 2015
Estimated Primary Completion Date:	July 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Testosterone gel: Active Comparator	Drug: AndroGel® (testosterone gel) AndroGel or placebo is applied to the torso, 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 7.5 g (containing 75 mg of testosterone) once a day.
Placebo gel: Placebo Comparator	Drug: AndroGel® (testosterone gel) AndroGel or placebo is applied to the torso, 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 7.5 g (containing 75 mg of testosterone) once a day.

Arms

Assigned Interventions

Testosterone gel: Active Comparator

Drug: AndroGel® (testosterone gel)

AndroGel or placebo is applied to the torso, 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 7.5 g (containing 75 mg of testosterone) once a day.

Placebo gel: Placebo Comparator

Drug: AndroGel® (testosterone gel)

AndroGel or placebo is applied to the torso, 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 7.5 g (containing 75 mg of testosterone) once a day.

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

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00799617

Contacts

Contact: Denise Cifelli, MS

215-573-4534

cifelli@mail.med.upenn.edu

Locations

United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
University of California San Diego
La Jolla, California, United States, 92093
University of California at Los Angeles
Torrance, California, United States, 90501
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06520
United States, Florida
University of Florida
Gainesville, Florida, United States, 32611
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60208
United States, Massachusetts
Boston University
Boston, Massachusetts, United States, 02215
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, New York
Albert Einstein College of Medicine
Bronx, New York, United States, 10461
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15261
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 76798
United States, Washington
University of Washington
Seattle, Washington, United States, 98108

Sponsors and Collaborators

University of Pennsylvania

Solvay Pharmaceuticals

Investigators

Principal Investigator:

Peter J Snyder, MD

University of Pennsylvania

More Information

Responsible Party:	University of Pennsylvania ( Peter J. Snyder, MD )
Study ID Numbers:	U01 AG030644
Study First Received:	November 26, 2008
Last Updated:	November 26, 2008
ClinicalTrials.gov Identifier:	NCT00799617
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Pennsylvania:

Testosterone
Mobility disability
Decreased libido

Age associated memory impairment
Low vitality
Anemia

Study placed in the following topic categories:

Testosterone
Anemia
Methyltestosterone
Testosterone 17 beta-cypionate

Additional relevant MeSH terms:

Anabolic Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Pharmacologic Actions
Androgens

ClinicalTrials.gov processed this record on January 16, 2009