Anastrozole Administration in Elderly Hypogonadal Men
3 other identifiers
interventional
88
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2004
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2004
CompletedFirst Submitted
Initial submission to the registry
August 25, 2005
CompletedFirst Posted
Study publicly available on registry
August 29, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedResults Posted
Study results publicly available
January 27, 2017
CompletedSeptember 13, 2022
August 1, 2022
4 years
August 25, 2005
November 30, 2016
August 16, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Lean Body Mass
Baseline and 1 year
Study Arms (2)
anastrozole
EXPERIMENTALanastrozole
placebo
PLACEBO COMPARATORplacebo
Interventions
Eligibility Criteria
You may qualify if:
- Men ages 60 and older
- Serum testosterone between 150-300 ng/dL
- Symptoms suggestive of androgen deficiency
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Massachusetts General Hospitallead
- National Institute on Aging (NIA)collaborator
Study Sites (1)
General Clinical Research Center, Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Related 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. doi: 10.1210/jc.2003-031467.
PMID: 15001605BACKGROUNDTaxel 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.
PMID: 11397902BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Benjamin Leder
- Organization
- Massachusetts General Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Benjamin Z. Leder, MD
Massachusetts General Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Invesitgator (MD)
Study Record Dates
First Submitted
August 25, 2005
First Posted
August 29, 2005
Study Start
October 1, 2004
Primary Completion
October 1, 2008
Study Completion
October 1, 2009
Last Updated
September 13, 2022
Results First Posted
January 27, 2017
Record last verified: 2022-08