Anastrozole Administration in Elderly Hypogonadal Men

Overview

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).

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: October 2008

Detailed Description

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 may provide a particularly 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.

Interventions

  • Drug: anastrozole
    • 1 mg QD

Arms, Groups and Cohorts

  • Experimental: anastrozole
    • anastrozole
  • Placebo Comparator: placebo
    • placebo

Clinical Trial Outcome Measures

Primary Measures

  • Change in Lean Body Mass
    • Time Frame: Baseline and 1 year

Participating in This Clinical Trial

Inclusion Criteria

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

Gender Eligibility: Male

Minimum Age: 60 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Massachusetts General Hospital
  • Collaborator
    • National Institute on Aging (NIA)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Benjamin Leder, MD, Principal Invesitgator (MD) – Massachusetts General Hospital
  • Overall Official(s)
    • Benjamin Z. Leder, MD, Principal Investigator, Massachusetts General Hospital

References

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.

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