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NCT00799617 · ClinicalTrials.gov registry record · Phase 3
The Testosterone Trials in Older Men
A Phase 3 study of Andropause, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 3
- Development phase
- 790
- Enrollment target
- 12
- Study locations
NCT00799617: Completed Phase 3 study of Andropause, sponsored by University of Pennsylvania.
NCT00799617 is a Phase 3 study of Andropause that has completed, run by University of Pennsylvania. The registered enrollment target is 790 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. The trial reports 12 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00799617, a Phase 3 study of Andropause, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 790 participants
- Enrollment target
- 12
- Study locations
Study Summary
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.
Primary Outcome
Baseline score and change in responses to Question 4 of the Psychosexual Daily Questionnaire (PDQ-Q4) from baseline to Month 12. Question 4 asks 12 questions about sexual activity. Scores on the PDQ-Q4 range from 0 to 12, with higher scores indicating more activity. The change is measured form the baseline value to Month 12.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG AndroGel® (testosterone gel)
Study Locations (12)
California
- University of California San Diego - La Jolla
- Center for Men's Health LA BioMed at Harbor-UCLA Medical Center - Torrance
Alabama
- University of Alabama at Birmingham - Birmingham
Connecticut
- Yale University - New Haven
Florida
- University of Florida - Gainesville
Illinois
- Northwestern University - Chicago
Massachusetts
- Boston University - Boston
Minnesota
- University of Minnesota - Minneapolis
New York
- Albert Einstein College of Medicine - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 790 participants |
| Start Date | 2009-11 |
| Est. Completion | 2018-12 |
| Phase | Phase 3 |
What the finished NCT00799617 record still lists
NCT00799617 is an interventional study that assigns participants to a tested intervention. The registered 790 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 1 condition, with Andropause appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00799617 lists 12 locations in 11 states (California, Alabama, Connecticut).
Frequently Asked Questions
What is clinical trial NCT00799617 about?
NCT00799617 is a clinical study titled "The Testosterone Trials in Older Men". 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 - a...
What is the current status of trial NCT00799617?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 790 participants. The study started on 2009-11. Estimated completion is 2018-12.
What conditions does trial NCT00799617 study?
This clinical trial studies the following conditions: Andropause.
What interventions are being tested in trial NCT00799617?
The interventions under investigation include: Placebo (DRUG), AndroGel® (testosterone gel) (DRUG).
Who is sponsoring clinical trial NCT00799617?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00799617 being conducted?
This trial has 12 study locations across Alabama, California, Connecticut, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00799617's enrollment target sits among peer trials
790 429th of 2000 higher than 1,570 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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