Anastrozole Administration in Elderly Hypogonadal Men
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ClinicalTrials.gov Identifier: NCT00136695 |
Recruitment Status :
Completed
First Posted : August 29, 2005
Results First Posted : January 27, 2017
Last Update Posted : January 27, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypogonadism | Drug: anastrozole | Phase 2 |
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 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 |

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 |
- Lean Body Mass [ Time Frame: 1 year ]

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Ages Eligible for Study: | 60 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Men ages 60 and older
- Serum testosterone between 150-300 ng/dL
- Symptoms suggestive of androgen deficiency

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
United States, Massachusetts | |
General Clinical Research Center, Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 |
Principal Investigator: | Benjamin Z. Leder, MD | Massachusetts General Hospital |
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 |
Aging |
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 |