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NCT00161421 · ClinicalTrials.gov registry record · Phase 2
Oral Androgens in Man-3 (ORAL T-3) Pharmacokinetics of Oral Testosterone
A Phase 2 study, sponsored by University of Washington.
- Completed
- Registry status
- Phase 2
- Development phase
- 18
- Enrollment target
NCT00161421: Completed Phase 2 study, sponsored by University of Washington.
NCT00161421 is a Phase 2 study that has completed, run by University of Washington. The registered enrollment target is 18 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00161421, a Phase 2 study, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 18 participants
- Enrollment target
Study Summary
The purpose of this study is to test the how the body absorbs and processes new forms of oral testosterone. Information gained during the study may help develop better forms of testosterone therapy in the future. We will be administering three drugs. Dutasteride is FDA approved to treat prostate enlargement. Lupron is approved for treatment of prostate cancer. Testosterone is approved for treatment of testicular insufficiency. They are being used in this study for "off-label" research purposes. This study will allow us to find out the effect of food on two formulations of testosterone taken by mouth, and the relative effect of food on testosterone absorption. Information from this study may be useful in treatment of men with low testosterone levels and the development of a male hormonal contraceptive.
Interventions
- DRUG Dutasteride
- DRUG Oral Testosterone
- DRUG Leuprolide (Lupron)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2005-03 |
| Est. Completion | 2006-07 |
| Phase | Phase 2 |
What the finished NCT00161421 record still lists
NCT00161421 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 3 interventions - of which Dutasteride is the first listed.
NCT00161421 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00161421 about?
NCT00161421 is a clinical study titled "Oral Androgens in Man-3 (ORAL T-3) Pharmacokinetics of Oral Testosterone". The purpose of this study is to test the how the body absorbs and processes new forms of oral testosterone. Information gained during the study may help develop better forms of testosterone therapy in the future. We will be administering three drugs. Dutasteride is FDA approved to treat prostate en...
What is the current status of trial NCT00161421?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2005-03. Estimated completion is 2006-07.
What interventions are being tested in trial NCT00161421?
The interventions under investigation include: Dutasteride (DRUG), Oral Testosterone (DRUG), Leuprolide (Lupron) (DRUG).
Who is sponsoring clinical trial NCT00161421?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00161421's enrollment target sits among peer trials
18 1898th of 2000 higher than 98 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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