Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
88 participants
INTERVENTIONAL
2004-10-31
2009-10-31
Brief Summary
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Detailed Description
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This study will recruit 150 male volunteers, 60 years of age or older, to be randomized to receive either anastrozole or a placebo for 24 months. Six visits are planned over the 96-week treatment period.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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anastrozole
anastrozole
anastrozole
1 mg QD
placebo
placebo
anastrozole
1 mg QD
Interventions
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anastrozole
1 mg QD
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Serum testosterone between 150-300 ng/dL
* Symptoms suggestive of androgen deficiency
60 Years
MALE
No
Sponsors
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National Institute on Aging (NIA)
NIH
Massachusetts General Hospital
OTHER
Responsible Party
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Benjamin Leder, MD
Principal Invesitgator (MD)
Principal Investigators
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Benjamin Z. Leder, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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General Clinical Research Center, Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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References
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Leder BZ, Rohrer JL, Rubin SD, Gallo J, Longcope C. Effects of aromatase inhibition in elderly men with low or borderline-low serum testosterone levels. J Clin Endocrinol Metab. 2004 Mar;89(3):1174-80. doi: 10.1210/jc.2003-031467.
Taxel P, Kennedy DG, Fall PM, Willard AK, Clive JM, Raisz LG. The effect of aromatase inhibition on sex steroids, gonadotropins, and markers of bone turnover in older men. J Clin Endocrinol Metab. 2001 Jun;86(6):2869-74. doi: 10.1210/jcem.86.6.7541.
Other Identifiers
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1R01AG025099-1A1
Identifier Type: -
Identifier Source: secondary_id
AG0035
Identifier Type: -
Identifier Source: org_study_id
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