- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00104572
Effects of Aromatase Inhibition Versus Testosterone in Older Men With Low Testosterone: Randomized-Controlled Trial.
The Effects of Aromatase Inhibition and Testosterone Replacement in Sex Steroids, Pituitary Hormones, Markers of Bone Turnover, Muscle Strength, and Cognition in Older Men
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21224
- National Institute of Aging, Clinical Research Unit
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: (Androgel) testosterone gel
17 participants will receive testosterone gel (5 gm) plus placebo tablet daily for 12 months and 'Calcium Cardone 500mg with vitamin D 400 IU'
|
1 mg tablet for 12 months
Daily for 12 months
1 tablet three times a day
|
Experimental: anastrozole (Aromatase inhibitor)
14 participants will receive anastrozole 1 mg tablet plus placebo gel daily for 12 months and 'Calcium Cardone 500mg with vitamin D 400 IU'
|
1 tablet three times a day
Daily for 12 months
|
Placebo Comparator: placebo
13 participants will receive a placebo tablet and placebo gel daily for 12 months and 'Calcium Cardone 500mg with vitamin D 400 IU'
|
Daily for 12 months
1 tablet three times a day
Daily for 12 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effect of Testosterone Gel vs. Anastrozole on Bone Mineral Density
Time Frame: 1 year
|
bone mineral density lumbar spine for all arms testosterone gel, anastrozole and placebo
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effect of Testosterone Gel vs. Anastrozole on Pulsatile Growth Hormone Release
Time Frame: 1 year
|
Overnight Growth hormone measures (total hormone secretion) for groups testosterone gel, anastrozole and placebo
|
1 year
|
Effect of Testosterone Gel vs. Anastrozole on Glucose Tolerance/Lipid Metabolism
Time Frame: 1 year
|
Primary outcome HOMA-IR for all groups testosterone gel, anastrozole and placebo Insulin resistance measure by HOMA-IR is a score if a person is insulin resistance the score should be between minimum 0.7- maximum 2 or more. Absolute changes in HOMAIR in all treatment arms, calculation time frame 1 year minus baseline point. |
1 year
|
Effect of Testosterone Gel vs. Anastrozole on Prostate Volume/Prostate Specific Antigen Levels/Urinary Function
Time Frame: 1 year
|
rectal ultrasound prostate volume for all groups testosterone gel, anastrozole and placebo. Absolute changes in prostate volume in all treatment arms, calculation time frame 1 year minus baseline point. |
1 year
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Jeffcoate SL, Brooks RV, Lim NY, London DR, Prunty FT, Spathis GS. Androgen production in hypogonadal men. J Endocrinol. 1967 Apr;37(4):401-11. doi: 10.1677/joe.0.0370401. No abstract available.
- Wheeler MJ. The determination of bio-available testosterone. Ann Clin Biochem. 1995 Jul;32 ( Pt 4):345-57. doi: 10.1177/000456329503200401. No abstract available.
- Gray A, Feldman HA, McKinlay JB, Longcope C. Age, disease, and changing sex hormone levels in middle-aged men: results of the Massachusetts Male Aging Study. J Clin Endocrinol Metab. 1991 Nov;73(5):1016-25. doi: 10.1210/jcem-73-5-1016.
- Dias JP, Melvin D, Shardell M, Ferrucci L, Chia CW, Gharib M, Egan JM, Basaria S. Effects of Transdermal Testosterone Gel or an Aromatase Inhibitor on Prostate Volume in Older Men. J Clin Endocrinol Metab. 2016 Apr;101(4):1865-71. doi: 10.1210/jc.2016-1111. Epub 2016 Mar 7.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Metabolic Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Endocrine System Diseases
- Gonadal Disorders
- Musculoskeletal Diseases
- Neuromuscular Manifestations
- Pathological Conditions, Anatomical
- Bone Diseases
- Muscular Atrophy
- Atrophy
- Bone Diseases, Metabolic
- Sarcopenia
- Osteoporosis
- Hypogonadism
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Micronutrients
- Hormone Antagonists
- Vitamins
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Steroid Synthesis Inhibitors
- Estrogen Antagonists
- Androgens
- Vitamin D
- Calcium
- Testosterone
- Anastrozole
- Aromatase Inhibitors
Other Study ID Numbers
- 999904338
- NCT00104572
- 04-AG-N338 (Other Identifier: NIHCC)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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