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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00104572
Recruitment Status : Completed
First Posted : March 2, 2005
Results First Posted : March 9, 2016
Last Update Posted : November 6, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute on Aging (NIA) )

Study Description
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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 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.

Condition or disease Intervention/treatment Phase
Hypogonadism Diabetes Sarcopenia Osteoporosis Depression Drug: Androgel (Testosterone Gel) Drug: Anastrozole (Aromatase Inhibitor) Drug: Placebo tablet Drug: Placebo gel Dietary Supplement: Calcium Cardone 500mg with vitamin D 400 IU Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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 Start Date : March 2004
Actual Primary Completion Date : December 2013
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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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'
 Drug: Androgel (Testosterone Gel)
1 mg tablet for 12 months

Drug: Placebo tablet
Daily for 12 months

Dietary Supplement: Calcium Cardone 500mg with vitamin D 400 IU
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'
 Drug: Anastrozole (Aromatase Inhibitor)
Drug: Placebo gel
Daily for 12 months

Dietary Supplement: Calcium Cardone 500mg with vitamin D 400 IU
1 tablet three times a day
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'
 Drug: Placebo tablet
Daily for 12 months

Drug: Placebo gel
Daily for 12 months

Dietary Supplement: Calcium Cardone 500mg with vitamin D 400 IU
1 tablet three times a day


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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.


  3. 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.



Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

  • INCLUSION CRITERIA:

    1. Men age 65 years or older
    2. Serum testosterone level less than or equal to 350 ng/dl
    3. Subject is able to complete an informed consent

EXCLUSION CRITERIA:

  1. History of Stroke
  2. History of Dementia
  3. History of Diabetes
  4. Blood pressure at rest of > 155/90 mmHg. Elevated systolic or diastolic reading renders subject ineligible
  5. Chronic medical condition, i.e. congestive heart failure
  6. Arthritis, severe enough to prevent completion of the strength testing, history of joint replacement of knees or hip.
  7. Inability to walk 50 meters

  8. Known disease of the bone and/or taking medications to treat osteoporosis, i.e.

    Fosamax, Evista, Miacalcin

  9. History of Gastric surgery
  10. History of prostate cancer or any other cancers, including blood dyscrasias
  11. History of severe benign prostatic hyperplasia (causing urinary problems)
  12. History of heart attack or open-heart surgery within the past 6 months
  13. Use of steroids within the past 3 months, including prednisone and/or cortisone injections, and inhaled steroids. Topical steroid cream is acceptable.
  14. If you do not agree to refrain from taking the drugs Viagra, Cialis or Levitra for the duration of the study
  15. 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
  16. Use of anti-androgen medications, i.e. Aldactone, Tagamet, Proscar, estrogens
  17. Use of Dilantin or Phenobarbital
  18. Alcohol intake > 30 grams (drink more than 2 beers per day OR more than 1 glass of wine or cocktail daily)
  19. Currently smokes any tobacco product
  20. Having started a new medication during the past three months which may interfere with the outcome measures of the study
  21. Polycythemia
  22. Prostate specific antigen > 4.0 ng/dl
  23. Hematocrit < 36
  24. Liver function tests greater than 2 times upper normal limits or abnormal electrolytes, calcium or Parathyroid hormone , at the discretion of the investigator
  25. Mini Mental Status Exam score less than or equal to 24
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00104572


Locations
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United States, Maryland
National Institute of Aging, Clinical Research Unit
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Josephine M Egan, M.D. National Institute on Aging (NIA)
More Information
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Publications:

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

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Responsible Party: National Institute on Aging (NIA)
ClinicalTrials.gov Identifier: NCT00104572    
Other Study ID Numbers: 999904338
04-AG-N338 ( Other Identifier: NIHCC )
First Posted: March 2, 2005    Key Record Dates
Results First Posted: March 9, 2016
Last Update Posted: November 6, 2018
Last Verified: March 2016
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute on Aging (NIA) ):
Estrogen
Glucose Tolerance
Bone Density
Quality-of-Life
Sarcopenia
Additional relevant MeSH terms:
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Osteoporosis
Sarcopenia
Hypogonadism
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Gonadal Disorders
Endocrine System Diseases
 Vitamin D
Anastrozole
Calcium
Testosterone
Aromatase Inhibitors
Vitamins
Micronutrients
Physiological Effects of Drugs
Calcium-Regulating Hormones and Agents
Bone Density Conservation Agents
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents