Effects of Aromatase Inhibition Versus Testosterone in Older Men With Low Testosterone: Randomized-Controlled Trial.

Phase

Condition

Diabetic Neuropathy

Diabetic Foot Ulcers

Diabetic Retinopathy

Treatment

N/A

Clinical Study ID

NCT00104572

999904338

04-AG-N338

Ages > 65
Male
Accepts Healthy Volunteers

Study 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 strength, bone density, sexual function, mood, and the ability to think to the best of one's ability. Testosterone replacement therapy often involves injections, patches, or gels that help to raise circulating testosterone levels, but these therapies often have side effects because they lead to imbalance of other hormones. Researchers have been studying the effectiveness of anastrozole, a drug that can lower estrogen levels while simultaneously increasing testosterone levels, as a treatment for the negative effects of decreased circulating testosterone levels that occur naturally with aging. Objectives: To evaluate whether anastrozole is as effective as testosterone gel in improving bone and muscle strength, hormone levels, and brain function in men over 65 years of age. Eligibility: Healthy men at least 65 years of age who have low levels of testosterone. Design: The study involves six study visits over a total of 12 months: screening, baseline, 6 weeks, 3 months, 6 months, and 12 months. All participants will receive calcium and vitamin D supplements to take daily, and will be randomized to one of three groups:Testosterone gel and placebo tablet, Anastrozole tablet and placebo gel, Placebo tablet and gel. Participants will have the following tests at each specified visit:Screening: Blood tests and rectal ultrasound to evaluate the prostate;Baseline: Blood and urine tests; growth hormone levels, muscle strength, bone density, and balance evaluation; imaging studies; cognitive testing; and questionnaires on quality of life, sexual function, depression, and urinary symptoms;Six weeks: Blood tests and dose adjustment of the gel or tablet;Three months: Blood and urine tests; growth hormone, muscle strength, bone density, and balance evaluation; and questionnaires on quality of life, sexual function, depression, and urinary symptoms;Six months: Blood and urine tests; muscle strength, bone density, and balance evaluation; cognitive testing; and questionnaires on quality of life, sexual function, depression, and urinary symptoms;Twelve months: Blood and urine tests; rectal ultrasound; muscle strength, bone density, and balance evaluation; imaging studies; cognitive testing; and questionnaires on quality of life, sexual function, depression, and urinary symptoms.

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

EXCLUSION CRITERIA:

History of Stroke
History of Dementia
History of Diabetes
Blood pressure at rest of > 155/90 mmHg. Elevated systolic or diastolic readingrenders subject ineligible
Chronic medical condition, i.e. congestive heart failure
Arthritis, severe enough to prevent completion of the strength testing, history ofjoint 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 cortisoneinjections, and inhaled steroids. Topical steroid cream is acceptable.
If you do not agree to refrain from taking the drugs Viagra, Cialis or Levitra for theduration 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 analogsof 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 ofwine or cocktail daily)
Currently smokes any tobacco product
Having started a new medication during the past three months which may interfere withthe 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 abnormalelectrolytes, calcium or Parathyroid hormone , at the discretion of the investigator
Mini Mental Status Exam score less than or equal to 24

Study Design

March 01, 2004

January 31, 2015

Study 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.

Connect with a study center

National Institute of Aging, Clinical Research Unit
Baltimore, Maryland 21224
United States
Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.