Anastrozole Administration in Elderly Hypogonadal Men

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Benjamin Leder, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00136695
First received: August 25, 2005
Last updated: October 23, 2013
Last verified: October 2013
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Anastrozole Administration in Elderly Hypogonadal Men

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • bone mineral density [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: October 2004
Study Completion Date: October 2009
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: anastrozole
anastrozole
Drug: anastrozole
1 mg QD
Other Name: arimidex
Placebo Comparator: placebo
placebo
Drug: anastrozole
1 mg QD
Other Name: arimidex

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Massachusetts General Hospital
Investigators
Principal Investigator: Benjamin Z. Leder, MD Massachusetts General Hospital
  More Information

Publications:
Responsible Party: Benjamin Leder, MD, Principal Invesitgator (MD), Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00136695     History of Changes
Other Study ID Numbers: AG0035, 5R01AG025099-05, 1R01AG025099-1A1
Study First Received: August 25, 2005
Last Updated: October 23, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
Aging

Additional relevant MeSH terms:
Hypogonadism
Endocrine System Diseases
Gonadal Disorders
Anastrozole
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014