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| Descriptive Information Fields | |||||
| Brief Title † | Decreased Testosterone Levels in Men Over 65 | ||||
| Official Title † | The Effects of Aromatase Inhibition on Sex Steroids, Pituitary Hormones, Markers of Bone Turnover, Muscle Strength and Cognition on Older Men | ||||
| Brief Summary | The purpose of this study is to determine if an aromatase inhibitor (a drug that inhibits the conversion of testosterone to estrogen) is as effective as testosterone replacement in improving muscle mass, muscle strength, sexual function, memory, and bone health. |
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| Detailed Description | Approximately 20% of men over the age of 70 have low testosterone levels. In some studies, testosterone replacement has resulted in improvement in bone mass, muscle strength, quality of life and memory function. In the body, testosterone is converted into estrogen. Hence, it is unclear whether these beneficial effects are due to testosterone or estrogen. Research has shown that inhibition of estrogen production in men results in an increase in testosterone levels. In this study, patients will be assigned to one of three groups: one group will receive testosterone gel and a placebo tablet, one group will receive a 1mg Anastrozole tablet and a placebo gel, and one group will receive a placebo tablet and placebo gel. Each group will receive a daily dose of calcium with vitamin D. The study requires 6 visits over a 12-month period for testing and evaluation. Two of the 6 visits will require an overnight stay in the hospital so that an intravenous (IV) line can be placed in the arm to allow samples to be drawn throughout the night. Testing will include a cardiac stress test, a glucose tolerance test, bone and muscle tests, evaluation of memory function, etc. For the safety of the prostate, we will perform a prostate ultrasound at the start and end of the study and we will monitor urinary symptoms, prostate specific antigen (PSA) levels and the prostate exam throughout the study. |
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| Study Phase | Phase III | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Primary Outcome Measure † | Improvements in bone quality, muscle strength, cardiac function, cognition, sexual and overall well-being [ Time Frame: 1 year ] [ Designated as safety issue: No ] Urinary symptoms [ Time Frame: 1 year ] [ Designated as safety issue: Yes ] Glucose tolerance [ Time Frame: 1 year ] [ Designated as safety issue: No ] Blood lab values [ Time Frame: 1 year ] [ Designated as safety issue: Yes ] |
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| Secondary Outcome Measure † | |||||
| Condition † | Aging Hypogonadism Andropause |
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| Intervention † | Drug: Anastrozole Drug: Testosterone Gel Drug: Placebo tablet Drug: Placebo gel Dietary Supplement: Calcium Cardone 500mg with vitamin D 400 IU |
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| MEDLINE PMIDs | 1719016, 7199020, 1856256, 9109845 | ||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 75 | ||||
| Start Date † | August 2004 | ||||
| Completion Date | May 2011 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||
| Ages | 65 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† |
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| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00104572 | ||||
| Organization ID | AG0018 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | National Institute on Aging (NIA) | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | National Institute on Aging (NIA) | ||||
| Verification Date | August 2008 | ||||
| First Received Date † | March 1, 2005 | ||||
| Last Updated Date | August 19, 2008 | ||||
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