The Testosterone Trial in Older Men - Full Text View

Sponsor:	University of Pennsylvania
Collaborators:	National Institute on Aging (NIA) National Institute of Neurological Disorders and Stroke (NINDS) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Heart, Lung, and Blood Institute (NHLBI) Abbott
Information provided by (Responsible Party):	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.

Two additional trials have been incorporated into the T Trial. Only men enrolled in the T Trial are eligible to participate in these trials.

The Cardiovascular Trial will examine if testosterone treatment results in more favorable changes in cardiovascular risk factors, compared to placebo.
The Bone Trial will test the hypothesis that testosterone treatment will increase volumetric trabecular bone mineral density (vBMD) of the lumbar spine as measured by quantitative computed tomography (QCT), compared with placebo treatment.

A Pharmacokinetic (PK) Study is also being conducted within the context of the interventional T Trial. It will examine the variability of the serum testosterone (T) concentration after application of testosterone gel or placebo, four months after the start of treatment.

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Randomized, Placebo-controlled, Double-blind Study of Five Coordinated Testosterone Treatment Trials in Older Men

Resource links provided by NLM:

MedlinePlus related topics: Anemia Memory

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

U.S. FDA Resources

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:	November 2009
Estimated Study Completion Date:	June 2015
Estimated Primary Completion Date:	November 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Testosterone gel	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.
Placebo Comparator: Placebo gel	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

Assigned Interventions

Active Comparator: Testosterone gel

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.

Placebo Comparator: Placebo gel

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.

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.

Participants will be treated with testosterone or placebo gel for 1 year. The dose will be adjusted in a blinded fashion to achieve a target T level range. Participants will be followed for one additional year following the treatment phase to assess adverse events.

Men participating in the Cardiovascular Trial will be assessed for changes in atherosclerotic plaque burden from 0 to 12 months.
Men participating in the Bone Trial will be assessed by QCT of the spine and hip, DXA of the spine and hip and clinical fractures at 0 and 12 months.
Men participating in the PK Study will attend 3 additional study visits for blood draws at the time of the 4 month assessment.

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 < 275 and < 300 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 >35% 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 >2.2 mg/dL; ALT 3x upper limit of normal; hemoglobin A1c >8.5%, TSH > 7.5mIU/L
Diagnosis or treatment for cancer within the past 3 years, with the exception of nonmelanotic skin cancer
Body mass index (BMI) >37 kg/m2
Mini Mental State Exam (MMSE) Score <24
• Major psychiatric disorders, including major depression (PHQ-9 score > 14), mania, hypomania, psychosis, schizophrenia or schizoaffective disorders, that are untreated, unstable, have resulted in hospitalization or medication change within the previous three months, or would result in inability to complete the trial efficacy instruments. Subjects whose disorders have been stable while being treated for more than three months 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
Opiate use within the past three 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

Participants in the T Trial may also enroll in the Cardiovascular and Bone Trials if it is determined that they are eligible based on the specific exclusion criteria.

Participation in the PK Study does not involve additional exclusion criteria.

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	Recruiting
Birmingham, Alabama, United States, 35294
Contact 205-934-2294
Principal Investigator: Cora E. Lewis, M.D., MSPH
United States, California
University of California San Diego	Recruiting
La Jolla, California, United States, 92093
Contact 877-219-6610
Principal Investigator: Elizabeth Barrett-Conner, M.D.
Center for Men's Health LA BioMed at Harbor-UCLA Medical Center	Recruiting
Torrance, California, United States, 90501
Contact 310-222-5297
Principal Investigator: Ronald Swerdloff, M.D.
United States, Connecticut
Yale University	Recruiting
New Haven, Connecticut, United States, 06520
Contact 203-737-5672
Contact 877.523.5672
Principal Investigator: Thomas Gill, M.D.
United States, Florida
University of Florida	Recruiting
Gainesville, Florida, United States, 32611
Contact 866-386-7730
Contact 352.273.5919
Principal Investigator: Marco Pahor, M.D.
United States, Illinois
Northwestern University	Recruiting
Chicago, Illinois, United States, 60208
Contact 877-300-3065
Principal Investigator: Mark E. Molitch, M.D.
United States, Massachusetts
Boston University	Recruiting
Boston, Massachusetts, United States, 02215
Contact 617-414-2968
Principal Investigator: Shalender Bhasin, M.D.
United States, Minnesota
University of Minnesota	Recruiting
Minneapolis, Minnesota, United States, 55455
Contact 612-625-4449
Principal Investigator: Kristine E. Ensrud, M.D., M.P.H.
United States, New York
Albert Einstein College of Medicine	Recruiting
Bronx, New York, United States, 10461
Contact 718-405-8271
Principal Investigator: Jill Crandall, M.D.
United States, Pennsylvania
University of Pittsburgh	Recruiting
Pittsburgh, Pennsylvania, United States, 15261
Contact 800-872-3653
Principal Investigator: Jane A. Cauley, DrPH
United States, Texas
Baylor College of Medicine	Recruiting
Houston, Texas, United States, 76798
Contact 713-798-8343
Principal Investigator: Glenn Cunningham, M.D.
United States, Washington
VA Puget Sound Health Care System	Recruiting
Seattle, Washington, United States, 98108
Contact 206-768-5408
Principal Investigator: Alvin M. Matsumoto, M.D.

Sponsors and Collaborators

University of Pennsylvania

National Institute on Aging (NIA)

National Institute of Neurological Disorders and Stroke (NINDS)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

National Heart, Lung, and Blood Institute (NHLBI)

Abbott

Investigators

Principal Investigator:

Peter J Snyder, MD

University of Pennsylvania

More Information

Additional Information:

Find out more information about The Testosterone Trial and the list of participating clinical sites. This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

No publications provided by University of Pennsylvania

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Meng J, Mostaghel EA, Vakar-Lopez F, Montgomery B, True L, Nelson PS. Testosterone regulates tight junction proteins and influences prostatic autoimmune responses. Horm Cancer. 2011 Jun;2(3):145-56.

Responsible Party:	University of Pennsylvania
ClinicalTrials.gov Identifier:	NCT00799617 History of Changes
Other Study ID Numbers:	U01 AG030644, R01 AG037679
Study First Received:	November 26, 2008
Last Updated:	January 10, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Pennsylvania:

Testosterone
Mobility disability
Decreased libido

Age associated memory impairment
Low vitality
Anemia

Additional relevant MeSH terms:

Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones

Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on February 09, 2012