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Anastrozole Administration in Elderly Hypogonadal Men

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00136695
Recruitment Status : Completed
First Posted : August 29, 2005
Results First Posted : January 27, 2017
Last Update Posted : January 27, 2017
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Benjamin Leder, MD, Massachusetts General Hospital

Study Description
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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).

Condition or disease Intervention/treatment Phase
Hypogonadism Drug: anastrozole Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Anastrozole Administration in Elderly Hypogonadal Men
Study Start Date : October 2004
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Anastrozole

Arms and Interventions
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Arm Intervention/treatment
Experimental: anastrozole
anastrozole
 Drug: anastrozole
1 mg QD
Other Name: arimidex
Placebo Comparator: placebo
placebo
 Drug: anastrozole
1 mg QD
Other Name: arimidex


Outcome Measures
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Primary Outcome Measures :
  1. Lean Body Mass [ Time Frame: 1 year ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00136695


Locations
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United States, Massachusetts
General Clinical Research Center, Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Benjamin Z. Leder, MD Massachusetts General Hospital
More Information
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Publications:

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Responsible Party: Benjamin Leder, MD, Principal Invesitgator (MD), Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00136695    
Other Study ID Numbers: AG0035
5R01AG025099-05 ( U.S. NIH Grant/Contract )
1R01AG025099-1A1
First Posted: August 29, 2005    Key Record Dates
Results First Posted: January 27, 2017
Last Update Posted: January 27, 2017
Last Verified: November 2016
Keywords provided by Benjamin Leder, MD, Massachusetts General Hospital:
Aging
Additional relevant MeSH terms:
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Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Anastrozole
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Aromatase Inhibitors
 Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs