Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00104572
Status:
COMPLETED
Last Update Posted:
2018-11-06
First Post:
2005-03-01
Brief Title:
Effects of Aromatase Inhibition Versus Testosterone in Older Men With Low Testosterone Randomized-Controlled Trial
Sponsor:
National Institute on Aging NIA
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
The Effects of Aromatase Inhibition and Testosterone Replacement in Sex Steroids Pituitary Hormones Markers of Bone Turnover Muscle Strength and Cognition in Older Men
Status:
COMPLETED
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background Men65 years often produce lower levels of testosterone meaning there is less testosterone circulating to the tissues of the body This is associated with negative effects on muscle strength bone density sexual function mood and the ability to think to the best of ones ability Testosterone replacement therapy often involves injections patches or gels that help to raise circulating testosterone levels but these therapies often have side effects because they lead to imbalance of other hormones Researchers have been studying the effectiveness of anastrozole a drug that can lower estrogen levels while simultaneously increasing testosterone levels as a treatment for the negative effects of decreased circulating testosterone levels that occur naturally with aging Objectives To evaluate whether anastrozole is as effective as testosterone gel in improving bone and muscle strength hormone levels and brain function in men over 65 years of age Eligibility Healthy men at least 65 years of age who have low levels of testosterone Design The study involves six study visits over a total of 12 months screening baseline 6 weeks 3 months 6 months and 12 months All participants will receive calcium and vitamin D supplements to take daily and will be randomized to one of three groupsTestosterone gel and placebo tablet Anastrozole tablet and placebo gel Placebo tablet and gel Participants will have the following tests at each specified visitScreening Blood tests and rectal ultrasound to evaluate the prostateBaseline Blood and urine tests growth hormone levels muscle strength bone density and balance evaluation imaging studies cognitive testing and questionnaires on quality of life sexual function depression and urinary symptomsSix weeks Blood tests and dose adjustment of the gel or tabletThree months Blood and urine tests growth hormone muscle strength bone density and balance evaluation and questionnaires on quality of life sexual function depression and urinary symptomsSix months Blood and urine tests muscle strength bone density and balance evaluation cognitive testing and questionnaires on quality of life sexual function depression and urinary symptomsTwelve months Blood and urine tests rectal ultrasound muscle strength bone density and balance evaluation imaging studies cognitive testing and questionnaires on quality of life sexual function depression and urinary symptoms
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCT00104572 | None | None | None |
| 04-AG-N338 | OTHER | NIHCC | None |