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NCT00490022 · ClinicalTrials.gov registry record · Phase 1
Effect of Dihydrotestosterone (DHT) on Prostate Tissue [Short Title: DHT-3]
A Phase 1 study, sponsored by University of Washington.
- Completed
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
NCT00490022: Completed Phase 1 study, sponsored by University of Washington.
NCT00490022 is a Phase 1 study that has completed, run by University of Washington. The registered enrollment target is 31 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00490022, a Phase 1 study, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
Study Summary
The purpose of this research study is to understand the effects of a male hormone normally made in the body called Dihydrotestosterone (DHT) on the prostate gland that is located under the bladder. The knowledge gained from this study may be used to help in the future to develop a safe male hormonal contraceptive to prevent pregnancy, in the safe treatment of low male hormone levels in men, and in the treatment and prevention of diseases of the prostate. The investigators will be giving DHT in a gel form, to be applied to the skin, or a placebo gel (with no active drug in it). The investigators want to see the effects of DHT on levels of hormones in the blood and in the prostate gland itself. In addition, the investigators will be studying the effects of DHT on the cells and genes expressed within the prostate. The effect of DHT on the prostate is not known. Some studies suggest blocking production of DHT in the prostate helps growth of the gland with aging (a condition known as benign prostatic hyperplasia, or BPH for short) and may prevent prostate cancer. On the other hand, DHT administration may shrink the prostate, suggesting it may be beneficial for some men. Therefore, further studies looking at the effect of DHT on the prostate are needed.
Primary Outcome
After 4 weeks of either daily dihydrotestosterone transdermal gel or placebo gel, subjects underwent a prostate biopsy. Intraprostatic hormone concentrations, specifically DHT and Testosterone, were measured. Unit of measure is ng/g.
Interventions
- DRUG Placebo gel
- DRUG Dihydrotestosterone (DHT) gel (0.7%)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2007-06 |
| Est. Completion | 2009-01 |
| Phase | Phase 1 |
What the finished NCT00490022 record still lists
NCT00490022 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo gel is the first listed.
NCT00490022 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00490022 about?
NCT00490022 is a clinical study titled "Effect of Dihydrotestosterone (DHT) on Prostate Tissue [Short Title: DHT-3]". The purpose of this research study is to understand the effects of a male hormone normally made in the body called Dihydrotestosterone (DHT) on the prostate gland that is located under the bladder. The knowledge gained from this study may be used to help in the future to develop a safe male hormonal...
What is the current status of trial NCT00490022?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2007-06. Estimated completion is 2009-01.
What interventions are being tested in trial NCT00490022?
The interventions under investigation include: Placebo gel (DRUG), Dihydrotestosterone (DHT) gel (0.7%) (DRUG).
Who is sponsoring clinical trial NCT00490022?
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 NCT00490022's enrollment target sits among peer trials
31 1322nd of 2000 higher than 669 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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