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Anastrozole Administration in Elderly Hypogonadal Men - Article


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Aging Skin

Liver Spots; Skin Aging 




Clinical Trial: Anastrozole Administration in Elderly Hypogonadal Men

This study is currently recruiting patients.
Verified by National Institute on Aging (NIA) August 2005

Sponsored by: National Institute on Aging (NIA)
Information provided by: National Institute on Aging (NIA)
ClinicalTrials.gov Identifier: NCT00136695

Purpose

The purpose of the study is to assess the effects of sustained aromatase inhibitor therapy to reduce estrogen levels in elderly men with mild hypogonadism (a decreased level of sex hormones).
Condition Intervention Phase
Hypogonadism
Aging
 Drug: anastrozole
Phase II

MedlinePlus related topics:  Endocrine Diseases

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Further Study Details: 
Primary Outcomes: strength; body composition; bone mineral density
Expected Total Enrollment:  150

Study start: October 2004;  Expected completion: October 2009

It has long been accepted that aging in men is associated with a slow, steady decline in gonadal androgen (male sex hormone) production. Several studies have explored androgen replacement, but the safety and efficacy of testosterone administration remains controversial. Aromatase inhibitors nay provide a particular useful way to restore normal androgen production in aging men.

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.

Eligibility

Ages Eligible for Study:  60 Years and above,  Genders Eligible for Study:  Male
Criteria

Inclusion Criteria:

  • Men ages 60 and older
  • Serum testosterone between 150-300 ng/dL
  • Symptoms suggestive of androgen deficiency

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00136695


Massachusetts
      General Clinical Research Center, Massachusetts General Hospital, Boston,  Massachusetts,  02114,  United States; Recruiting
Rachel Cohen, BA  617-726-2860    rcohen6@partners.org 
Sarah Comeaux, BA  617-726-6129    scomeaux@partners.org 

Study chairs or principal investigators

Benjamin Z. Leder, MD,  Principal Investigator,  Massachusetts General Hospital   

More Information

Publications

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.

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.

Study ID Numbers:  AG0035; 1R01AG025099-1A1
Last Updated:  August 26, 2005
Record first received:  August 25, 2005
ClinicalTrials.gov Identifier:  NCT00136695
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-30

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November 27, 2009



Page Updated: October 15, 2009
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