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Decreased Testosterone Levels in Men Over 65

This study is currently recruiting participants.
Information provided by National Institute on Aging (NIA)

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Descriptive Information Fields
Brief Title  Decreased Testosterone Levels in Men Over 65
Official Title  The Effects of Aromatase Inhibition on Sex Steroids, Pituitary Hormones, Markers of Bone Turnover, Muscle Strength and Cognition on Older Men
Brief Summary

The purpose of this study is to determine if an aromatase inhibitor (a drug that inhibits the conversion of testosterone to estrogen) is as effective as testosterone replacement in improving muscle mass, muscle strength, sexual function, memory, and bone health.

Detailed Description

Approximately 20% of men over the age of 70 have low testosterone levels. In some studies, testosterone replacement has resulted in improvement in bone mass, muscle strength, quality of life and memory function. In the body, testosterone is converted into estrogen. Hence, it is unclear whether these beneficial effects are due to testosterone or estrogen. Research has shown that inhibition of estrogen production in men results in an increase in testosterone levels.

In this study, patients will be assigned to one of three groups: one group will receive testosterone gel and a placebo tablet, one group will receive a 1mg Anastrozole tablet and a placebo gel, and one group will receive a placebo tablet and placebo gel. Each group will receive a daily dose of calcium with vitamin D. The study requires 6 visits over a 12-month period for testing and evaluation. Two of the 6 visits will require an overnight stay in the hospital so that an intravenous (IV) line can be placed in the arm to allow samples to be drawn throughout the night. Testing will include a cardiac stress test, a glucose tolerance test, bone and muscle tests, evaluation of memory function, etc. For the safety of the prostate, we will perform a prostate ultrasound at the start and end of the study and we will monitor urinary symptoms, prostate specific antigen (PSA) levels and the prostate exam throughout the study.

Study Phase Phase III
Study Type  Interventional
Study Design  Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measure  Improvements in bone quality, muscle strength, cardiac function, cognition, sexual and overall well-being [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Urinary symptoms [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Glucose tolerance [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Blood lab values [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Secondary Outcome Measure 
Condition  Aging
Hypogonadism
Andropause
Intervention  Drug: Anastrozole
Drug: Testosterone Gel
Drug: Placebo tablet
Drug: Placebo gel
Dietary Supplement: Calcium Cardone 500mg with vitamin D 400 IU
MEDLINE PMIDs 1719016,   7199020,   1856256,   9109845
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  75
Start Date  August 2004
Completion Date May 2011
Eligibility Criteria 

Inclusion Criteria:

  • Male
  • 65 years of age or older
  • Testosterone level less than 350 ng/dl (we will check this level at the screening visit)
  • Able to complete an informed consent

Exclusion Criteria:

  • History of Stroke
  • History of Dementia
  • History of Diabetes
  • Blood Pressure at rest of > 155/90 mm Hg
  • Chronic medical condition (i.e. heart failure, rheumatoid arthritis)
  • On osteoporosis medications
  • On steroids (prednisone, cortisone)
  • History of gastric surgery
  • History of any Cancer (except non-melanoma skin cancers)
  • Drink more than 2 beers OR 1 glass of wine or cocktail daily
  • Smoke any tobacco product
  • Started a new medication within the past three months
  • History of joint replacement
Gender Male
Ages 65 Years and older
Accepts Healthy Volunteers No
Contacts ††
Contact: Denise Melvin     410-350-3924     melvinde@grc.nia.nih.gov    
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00104572
Organization ID AG0018
Secondary IDs ††
Study Sponsor  National Institute on Aging (NIA)
Collaborators ††
Investigators 
Principal Investigator:     Josephine M Egan, MD     Chief, Diabetes Section, LCI/NIA/NIH    
Information Provided By National Institute on Aging (NIA)
Verification Date August 2008
First Received Date  March 1, 2005
Last Updated Date August 19, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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