The Testosterone Trials in Older Men
Public ClinicalTrials.gov record NCT00799617. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Randomized, Placebo-controlled, Double-blind Study of Seven Coordinated Testosterone Treatment Trials in Older Men
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The Testosterone Trials are a multi-center set of trials involving 12 clinical sites geographically distributed across the United States. The primary specific aims are to test the hypotheses that testosterone treatment of elderly men whose serum testosterone concentrations are unequivocally low - and who have symptoms and objectively measured abnormalities in at least one of five areas that could be due to low testosterone (physical or sexual function, vitality, cognition, and anemia) - will result in more favorable changes in those abnormalities than placebo treatment. Two additional trials have been incorporated into the T Trial. Only men enrolled in the T Trial are eligible to participate in these trials. * The Cardiovascular Trial will examine if testosterone treatment results in more favorable changes in cardiovascular risk factors, compared to placebo. * The Bone Trial will test the hypothesis that testosterone treatment will increase volumetric trabecular bone mineral density (vBMD) of the lumbar spine as measured by quantitative computed tomography (QCT), compared with placebo treatment. A Pharmacokinetic (PK) Study is also being conducted within the context of the interventional T Trial. It will examine the variability of the serum testosterone (T) concentration after application of testosterone gel or placebo, four months after the start of treatment.
Study identification
- NCT ID
- NCT00799617
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 790 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 65 Years and older
- Sex
- Male
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 31, 2009
- Primary completion
- Jun 30, 2014
- Completion
- Nov 30, 2018
- Last update posted
- Feb 20, 2019
2009 – 2018
United States locations
- U.S. sites
- 12
- U.S. states
- 11
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | — |
| University of California San Diego | La Jolla | California | 92093 | — |
| Center for Men's Health LA BioMed at Harbor-UCLA Medical Center | Torrance | California | 90501 | — |
| Yale University | New Haven | Connecticut | 06520 | — |
| University of Florida | Gainesville | Florida | 32611 | — |
| Northwestern University | Chicago | Illinois | 60208 | — |
| Boston University | Boston | Massachusetts | 02215 | — |
| University of Minnesota | Minneapolis | Minnesota | 55455 | — |
| Albert Einstein College of Medicine | The Bronx | New York | 10461 | — |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15261 | — |
| Baylor College of Medicine | Houston | Texas | 76798 | — |
| VA Puget Sound Health Care System | Seattle | Washington | 98108 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00799617, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 20, 2019 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00799617 live on ClinicalTrials.gov.