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| Sponsored by: |
National Institute on Aging (NIA) |
| Information provided by: | National Institute on Aging (NIA) |
| ClinicalTrials.gov Identifier: | NCT00104572 |
Purpose
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.
| Condition | Intervention | Phase |
|
Aging Hypogonadism Andropause |
Drug: Anastrozole Drug: Testosterone Gel |
Phase III |
| Genetics Home Reference related topics: | Endocrine Diseases |
| MedlinePlus related topics: | Memory |
| ChemIDplus related topics: | Testosterone Methyltestosterone Oxymesterone Testosterone enanthate Testosterone Propionate Testosterone undecanoate Anastrozole Dextrose |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | The Effects of Aromatase Inhibition on Sex Steroids, Pituitary Hormones, Markers of Bone Turnover, Muscle Strength and Cognition on Older Men |
| Estimated Enrollment: | 75 |
| Study Start Date: | August 2004 |
| Estimated Study Completion Date: | February 2007 |
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.
Eligibility
| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Denise Melvin | 410-350-3924 | melvinde@grc.nia.nih.gov |
| United States, Maryland | |||||
| National Institute on Aging (NIA), Harbor Hospital | Recruiting | ||||
| Baltimore, Maryland, United States, 21225 | |||||
| Contact: Denise Melvin, Study Coordinator 410-350-3924 or 800-225-2572 ext 3924 melvinde@grc.nia.nih.gov | |||||
| Contact: Sara Betkey, Participant Recruitment 410-350-3941 or 800-225-2572 ext 3941 betkeys@grc.nia.nih.gov | |||||
| Sub-Investigator: Shehzad Basaria, MD | |||||
| Principal Investigator: | Josephine M Egan, MD | Chief, Diabetes Section, LCI/NIA/NIH |
More Information
| Study ID Numbers: | AG0018 |
| First Received: | March 1, 2005 |
| Last Updated: | September 19, 2007 |
| ClinicalTrials.gov Identifier: | NCT00104572 |
| Health Authority: | United States: Federal Government |
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