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NCT00490555 · ClinicalTrials.gov registry record · Phase 2
PROS-1-Male Hormonal Contraceptive Regimens on Prostate Tissue
A Phase 2 study, sponsored by University of Washington.
- Completed
- Registry status
- Phase 2
- Development phase
- 32
- Enrollment target
NCT00490555: Completed Phase 2 study, sponsored by University of Washington.
NCT00490555 is a Phase 2 study that has completed, run by University of Washington. The registered enrollment target is 32 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (76% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00490555, a Phase 2 study, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 32 participants
- Enrollment target
Study Summary
The investigators propose to examine the in vivo responses to hormonal manipulation at the molecular level directly in the tissue of interest (prostate). As in the investigators' previous, pilot study, the investigators will use the novel approach of procuring tissue specimens from normal, healthy men who might be chose to use a male hormonal contraceptive regimen were it available. The investigators will employ state of the art techniques such as laser capture microdissection (LCM) and cDNA microarrays to determine the tissue-specific consequences of male hormonal contraceptive regimens on the prostate. The results will help guide the design, safety monitoring, and selection of male hormonal contraceptive agents and provide valuable insights into prostate human prostate biology. The investigators will test the hypothesis that exogenous T administration that results in increased circulating T and dihydrotestosterone (DHT) levels will increase intraprostatic concentrations of T and its metabolite DHT. The investigators will test the hypothesis that the addition of a potent 5α-reductase inhibitor, dutasteride, or the progestin, Depomedoxyprogesterone (IM DMPA), to T administration in young and middle aged men will decrease intraprostatic DHT and increase intraprostatic T concentrations compared to T alone. The investigators will test the hypothesis that the addition of a 5α-reductase inhibitor dutasteride or the progestin IM DMPA to exogenous T, by reducing intraprostatic DHT, will decrease prostate epithelial proliferation, assessed by Ki-67 labeling index (Ki-67LI), and increase apoptosis, assessed by caspase-3 expression, and decrease androgen-regulated protein expression such as prostate specific antigen (PSA). The investigators will test the hypothesis that the addition of a 5α-reductase inhibitor or the progestin IM DMPA to exogenous T, by modifying the intraprostatic hormonal milieu, will alter prostate epithelial gene expression. Specifically, the investig
Primary Outcome
PSA level week 10 end of treatment
Interventions
- DRUG Dutasteride
- DRUG Testosterone gel
- DRUG Depo-Medroxyprogesterone (DMPA)
- OTHER Placebo Testosterone gel
- OTHER Placebo dutasteride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2009-01 |
| Est. Completion | 2012-03 |
| Phase | Phase 2 |
What the finished NCT00490555 record still lists
NCT00490555 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (76% lower).
The record links to 0 conditions, and to 5 interventions - of which Dutasteride is the first listed.
NCT00490555 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00490555 about?
NCT00490555 is a clinical study titled "PROS-1-Male Hormonal Contraceptive Regimens on Prostate Tissue". The investigators propose to examine the in vivo responses to hormonal manipulation at the molecular level directly in the tissue of interest (prostate). As in the investigators' previous, pilot study, the investigators will use the novel approach of procuring tissue specimens from normal, healthy m...
What is the current status of trial NCT00490555?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 32 participants. The study started on 2009-01. Estimated completion is 2012-03.
What interventions are being tested in trial NCT00490555?
The interventions under investigation include: Dutasteride (DRUG), Testosterone gel (DRUG), Depo-Medroxyprogesterone (DMPA) (DRUG), Placebo Testosterone gel (OTHER), Placebo dutasteride (OTHER).
Who is sponsoring clinical trial NCT00490555?
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 NCT00490555's enrollment target sits among peer trials
32 1563rd of 2000 higher than 423 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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