Anastrozole Administration in Elderly Hypogonadal Men
This study has been completed.
Sponsor:
Massachusetts General Hospital
Collaborator:
Information provided by (Responsible Party):
Benjamin Leder, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00136695
First received: August 25, 2005
Last updated: April 22, 2013
Last verified: April 2013
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | August 25, 2005 | ||||
| Last Updated Date | April 22, 2013 | ||||
| Start Date ICMJE | October 2004 | ||||
| Primary Completion Date | October 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
bone mineral density [ Time Frame: 2 years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
|
||||
| Change History | Complete list of historical versions of study NCT00136695 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Anastrozole Administration in Elderly Hypogonadal Men | ||||
| Official Title ICMJE | Anastrozole Administration in Elderly Hypogonadal Men | ||||
| 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. |
||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
||||
| Condition ICMJE | Hypogonadism | ||||
| Intervention ICMJE | Drug: anastrozole
1 mg QD
Other Name: arimidex |
||||
| Study Arm (s) |
|
||||
| Publications * |
|
||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 100 | ||||
| Completion Date | October 2009 | ||||
| Primary Completion Date | October 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
|
||||
| Gender | Male | ||||
| Ages | 60 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00136695 | ||||
| Other Study ID Numbers ICMJE | AG0035, 5R01AG025099-05, 1R01AG025099-1A1 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Benjamin Leder, MD, Massachusetts General Hospital | ||||
| Study Sponsor ICMJE | Massachusetts General Hospital | ||||
| Collaborators ICMJE | National Institute on Aging (NIA) | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Massachusetts General Hospital | ||||
| Verification Date | April 2013 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||