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NCT00136695 Clinical Trial

Anastrozole Administration in Elderly Hypogonadal Men

Hypogonadism Clinical Trial

Official title:
Anastrozole Administration in Elderly Hypogonadal Men

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00136695
Other study ID # AG0035
Secondary ID 5R01AG025099-051
Status Completed
Phase Phase 2
First received
Last updated
Start date October 2004
Est. completion date October 2009

Study information
Verified date August 2022
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility
Status Completed
Enrollment 88
Est. completion date October 2009
Est. primary completion date October 2008
Accepts healthy volunteers No
Gender Male
Age group 60 Years and older
Eligibility Inclusion Criteria: - Men ages 60 and older - Serum testosterone between 150-300 ng/dL - Symptoms suggestive of androgen deficiency

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• anastrozole
1 mg QD

Locations
Country Name City State
United States General Clinical Research Center, Massachusetts General Hospital Boston Massachusetts

Sponsors (2)
Lead Sponsor Collaborator
Massachusetts General Hospital National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Lean Body Mass Baseline and 1 year
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