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NCT00104572 · ClinicalTrials.gov registry record · Phase 2
Effects of Aromatase Inhibition Versus Testosterone in Older Men With Low Testosterone: Randomized-Controlled Trial.
A Phase 2 study, sponsored by National Institute on Aging (NIA).
- Completed
- Registry status
- Phase 2
- Development phase
- 44
- Enrollment target
NCT00104572 is a Phase 2 study that has completed, run by National Institute on Aging (NIA). The registered enrollment target is 44 participants.
The verdict
NCT00104572, a Phase 2 study, has completed, sponsored by National Institute on Aging (NIA).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 44 participants
- Enrollment target
Study Summary
Background: Men≥65 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 one's 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 groups:Testosterone gel and placebo tablet, Anastrozole tablet and placebo gel, Placebo tablet and gel. Participants will have the following tests at each specified visit:Screening: Blood tests and rectal ultrasound to evaluate the prostate;Baseline: 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 symptoms;Six weeks: Blood tests and dose adjustment of the gel or tablet;Three months: Blood and urine tests; growth hormone, muscle strength, bone density, and balance evaluation; and questionnaires on quality of
Interventions
- DRUG Placebo tablet
- DRUG Placebo gel
- DRUG Androgel (Testosterone Gel)
- DRUG Anastrozole (Aromatase Inhibitor)
- DIETARY_SUPPLEMENT Calcium Cardone 500mg with vitamin D 400 IU
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2004-03 |
| Est. Completion | 2015-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00104572
The ClinicalTrials.gov registry entry for NCT00104572 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute on Aging (NIA), which has 131 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Placebo tablet is the first listed.
NCT00104572 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00104572 about?
NCT00104572 is a clinical study titled "Effects of Aromatase Inhibition Versus Testosterone in Older Men With Low Testosterone: Randomized-Controlled Trial.". Background: Men≥65 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 one's ability. Tes...
What is the current status of trial NCT00104572?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 44 participants. The study started on 2004-03. Estimated completion is 2015-01.
What interventions are being tested in trial NCT00104572?
The interventions under investigation include: Placebo tablet (DRUG), Placebo gel (DRUG), Androgel (Testosterone Gel) (DRUG), Anastrozole (Aromatase Inhibitor) (DRUG), Calcium Cardone 500mg with vitamin D 400 IU (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT00104572?
This trial is sponsored by National Institute on Aging (NIA), which has 131 total clinical trials registered on ClinicalTrials.gov.
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