Anastrozole Administration in Elderly Hypogonadal Men

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).

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Key information

Conditions

Hypogonadism Endocrine System Diseases Gonadal Disorders

Age range

60 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

General Clinical Research Center, Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Anastrozole

Drug

1 mg QD

Other names: arimidex

Primary outcomes

Change in Lean Body Mass

Time frame: Baseline and 1 year

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

National Institute on Aging (NIA)

Registry information

Important dates

Study start: 2004
Primary completion: 2008
Study completion: 2009
First posted: Aug 29, 2005
Registry last updated: Sep 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed