Status:
COMPLETED
Effects of Aromatase Inhibition Versus Testosterone in Older Men With Low Testosterone: Randomized-Controlled Trial.
Lead Sponsor:
National Institute on Aging (NIA)
Conditions:
Hypogonadism
Diabetes
Eligibility:
MALE
65+ years
Phase:
PHASE2
Brief Summary
Background: Men≥65 years often produce lower levels of testosterone, meaning there is less testosterone circulating to the tissues of the body. This is associated with negative effects on muscle stren...
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 memor...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Men age 65 years or older
- Serum testosterone level less than or equal to 350 ng/dl
- Subject is able to complete an informed consent
- EXCLUSION CRITERIA:
- History of Stroke
- History of Dementia
- History of Diabetes
- Blood pressure at rest of \> 155/90 mmHg. Elevated systolic or diastolic reading renders subject ineligible
- Chronic medical condition, i.e. congestive heart failure
- Arthritis, severe enough to prevent completion of the strength testing, history of joint replacement of knees or hip.
- Inability to walk 50 meters
- Known disease of the bone and/or taking medications to treat osteoporosis, i.e.
- Fosamax, Evista, Miacalcin
- History of Gastric surgery
- History of prostate cancer or any other cancers, including blood dyscrasias
- History of severe benign prostatic hyperplasia (causing urinary problems)
- History of heart attack or open-heart surgery within the past 6 months
- Use of steroids within the past 3 months, including prednisone and/or cortisone injections, and inhaled steroids. Topical steroid cream is acceptable.
- If you do not agree to refrain from taking the drugs Viagra, Cialis or Levitra for the duration of the study
- Use of anabolic steroids, i.e. testosterone, (or any analog of testosterone) Dehydroepiandrosterone or any growth promoters i.e. growth hormone itself or analogs of growth hormone
- Use of anti-androgen medications, i.e. Aldactone, Tagamet, Proscar, estrogens
- Use of Dilantin or Phenobarbital
- Alcohol intake \> 30 grams (drink more than 2 beers per day OR more than 1 glass of wine or cocktail daily)
- Currently smokes any tobacco product
- Having started a new medication during the past three months which may interfere with the outcome measures of the study
- Polycythemia
- Prostate specific antigen \> 4.0 ng/dl
- Hematocrit \< 36
- Liver function tests greater than 2 times upper normal limits or abnormal electrolytes, calcium or Parathyroid hormone , at the discretion of the investigator
- Mini Mental Status Exam score less than or equal to 24
Exclusion
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00104572
Start Date
March 1 2004
End Date
January 1 2015
Last Update
November 6 2018
Active Locations (1)
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1
National Institute of Aging, Clinical Research Unit
Baltimore, Maryland, United States, 21224