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Anastrozole Administration in Elderly Hypogonadal Men

Primary Purpose

Hypogonadism

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

anastrozole

About this trial

This is an interventional treatment trial for Hypogonadism focused on measuring Aging

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

General Clinical Research Center, Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

anastrozole

placebo

Arm Description

anastrozole

placebo

Outcomes

Primary Outcome Measures

Change in Lean Body Mass

Secondary Outcome Measures

Full Information

NCT ID

NCT00136695

First Posted

August 25, 2005

Last Updated

August 16, 2022

Sponsor

Massachusetts General Hospital

Collaborators

National Institute on Aging (NIA)

1. Study Identification

Unique Protocol Identification Number

NCT00136695

Brief Title

Anastrozole Administration in Elderly Hypogonadal Men

Official Title

Anastrozole Administration in Elderly Hypogonadal Men

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Completed

Study Start Date

October 2004 (undefined)

Primary Completion Date

October 2008 (Actual)

Study Completion Date

October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

Collaborators

National Institute on Aging (NIA)

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypogonadism

Keywords

Aging

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

88 (Actual)

8. Arms, Groups, and Interventions

Arm Title

anastrozole

Arm Type

Experimental

Arm Description

anastrozole

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

placebo

Intervention Type

Drug

Intervention Name(s)

anastrozole

Other Intervention Name(s)

arimidex

Intervention Description

1 mg QD

Primary Outcome Measure Information:

Title

Change in Lean Body Mass

Time Frame

Baseline and 1 year

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Benjamin Z. Leder, MD

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

General Clinical Research Center, Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

15001605

Citation

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.

Results Reference

background

PubMed Identifier

11397902

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. doi: 10.1210/jcem.86.6.7541.

Results Reference

background

Learn more about this trial

Anastrozole Administration in Elderly Hypogonadal Men

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