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Decreased Testosterone Levels in Men Over 65
This study is currently recruiting participants.
Verified October 2010 by National Institutes of Health Clinical Center (CC)

First Received on March 1, 2005.   Last Updated on October 15, 2010   History of Changes
Sponsor: National Institute on Aging (NIA)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00104572
  Purpose

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.


Condition Intervention Phase
Aging
Hypogonadism
Andropause
Drug: Anastrozole
Drug: Testosterone Gel
Drug: Placebo tablet
Drug: Placebo gel
Dietary Supplement: Calcium Cardone 500mg with vitamin D 400 IU
Phase III

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Aromatase Inhibition on Sex Steroids, Pituitary Hormones, Markers of Bone Turnover, Muscle Strength and Cognition on Older Men

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 75
Study Start Date: August 2004
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
25 participants will receive testosterone gel (5 gm) plus placebo tablet daily for 12 months
Drug: Testosterone Gel
5.0 - 7.5 mg gel daily for 12 months
Other Name: Androgel
Drug: Placebo tablet
Daily for 12 months
Dietary Supplement: Calcium Cardone 500mg with vitamin D 400 IU
1 tablet three times a day
Other Name: OsCal
Experimental: 2
25 participants will receive anastrozole 1 mg tablet plus placebo gel daily for 12 months
Drug: Anastrozole
1 mg tablet daily for 12 months
Other Name: Arimidex
Dietary Supplement: Calcium Cardone 500mg with vitamin D 400 IU
1 tablet three times a day
Other Name: OsCal
Placebo Comparator: 3
25 participants will receive a placebo tablet and placebo gel daily for 12 months
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
Other Name: OsCal

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00104572

Contacts
Contact: Denise Melvin 410-350-3924 melvinde@grc.nia.nih.gov

Locations
United States, Maryland
National Institute on Aging (NIA), Harbor Hospital Recruiting
Baltimore, Maryland, United States, 21225
Contact: Denise Melvin, Study Coordinator     410-350-3924 or 800-225-2572 ext 3924     melvinde@grc.nia.nih.gov    
Contact: NIA Recruiter     410-350-3941     NIAStudiesRecruitment@mail.nih.gov    
Sponsors and Collaborators
Investigators
Principal Investigator: Josephine M Egan, MD Chief, Diabetes Section, LCI/NIA/NIH
  More Information

Publications:
Responsible Party: Josephine Egan, MD, Principal Investigator, National Institute on Aging
ClinicalTrials.gov Identifier: NCT00104572     History of Changes
Other Study ID Numbers: AG0018
Study First Received: March 1, 2005
Last Updated: October 15, 2010
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Low testosterone level
glucose tolerance
estrogen
bone density
quality of life
memory function
sarcopenia

Additional relevant MeSH terms:
Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Anastrozole
Vitamin D
Vitamins
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents
Bone Density Conservation Agents
Micronutrients
Growth Substances
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 12, 2012