Anastrozole Administration in Elderly Hypogonadal Men

This study is ongoing, but not recruiting participants.

First Received: August 25, 2005 Last Updated: January 25, 2007 History of Changes

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	Drug: anastrozole	Phase II

Drug Information available for: Anastrozole

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Anastrozole Administration in Elderly Hypogonadal Men

Further study details as provided by National Institute on Aging (NIA):

Primary Outcome Measures:

strength
body composition
bone mineral density

Estimated Enrollment:	150
Study Start Date:	October 2004
Estimated Study Completion Date:	October 2009

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.

Eligibility

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00136695

Locations

United States, Massachusetts
General Clinical Research Center, Massachusetts General Hospital
Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

National Institute on Aging (NIA)

Investigators

Principal Investigator:

Benjamin Z. Leder, MD

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
Study First Received:	August 25, 2005
Last Updated:	January 25, 2007
ClinicalTrials.gov Identifier:	NCT00136695 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Institute on Aging (NIA):

Aging

Study placed in the following topic categories:

Anastrozole
Hypogonadism
Antineoplastic Agents, Hormonal
Gonadal Disorders

Endocrine System Diseases
Endocrinopathy
Aromatase Inhibitors

Additional relevant MeSH terms:

Anastrozole
Hypogonadism
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Gonadal Disorders

Therapeutic Uses
Endocrine System Diseases
Enzyme Inhibitors
Aromatase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009