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NCT00106392 · ClinicalTrials.gov registry record · Phase 4
A Safety and Efficacy Study of Prograf in the Prevention of Erectile Dysfunction After Radical Prostatectomy
A Phase 4 study of Prostate Cancer and Erectile Dysfunction, sponsored by Astellas Pharma.
- Completed
- Registry status
- Phase 4
- Development phase
- 131
- Enrollment target
- 6
- Study locations
NCT00106392: Completed Phase 4 study of Prostate Cancer and Erectile Dysfunction, sponsored by Astellas Pharma.
NCT00106392 is a Phase 4 study of Prostate Cancer and Erectile Dysfunction that has completed, run by Astellas Pharma. The registered enrollment target is 131 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (78% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00106392, a Phase 4 study of Prostate Cancer and Erectile Dysfunction, has completed, sponsored by Astellas Pharma.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 131 participants
- Enrollment target
- 6
- Study locations
Study Summary
The purpose of the study is to compare the safety and effectiveness of Prograf in the prevention of erectile dysfunction in men after a radical prostatectomy.
Primary Outcome
Erectile function was assessed using the International Index of Erectile Function (IIEF) questionnaire, which consists of 15 questions. The erectile function domain score is calculated as a sum of scores from questions 1-5 and 15. A clinically meaningful difference is 5 points. The scores range from 1 to 30 points where a higher score indicates better erectile function. Normal erectile function is defined as greater than or equal to 24 points.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Tacrolimus
Study Locations (6)
New York
- - New York
- - New York
Michigan
- - Ann Arbor
Ohio
- - Cleveland
Tennessee
- - Nashville
Texas
- - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 131 participants |
| Start Date | 2005-02 |
| Est. Completion | 2008-11 |
| Phase | Phase 4 |
What the finished NCT00106392 record still lists
NCT00106392 is an interventional study that assigns participants to a tested intervention. The registered 131 participants enrollment target is mid-sized for trials with a published cap, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (78% lower).
The record links to 2 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00106392 lists 6 locations in 5 states (New York, Michigan, Ohio).
Frequently Asked Questions
What is clinical trial NCT00106392 about?
NCT00106392 is a clinical study titled "A Safety and Efficacy Study of Prograf in the Prevention of Erectile Dysfunction After Radical Prostatectomy". The purpose of the study is to compare the safety and effectiveness of Prograf in the prevention of erectile dysfunction in men after a radical prostatectomy.
What is the current status of trial NCT00106392?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 131 participants. The study started on 2005-02. Estimated completion is 2008-11.
What conditions does trial NCT00106392 study?
This clinical trial studies the following conditions: Prostate Cancer, Erectile Dysfunction.
What interventions are being tested in trial NCT00106392?
The interventions under investigation include: Placebo (DRUG), Tacrolimus (DRUG).
Who is sponsoring clinical trial NCT00106392?
This trial is sponsored by Astellas Pharma, which has 165 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00106392 being conducted?
This trial has 6 study locations across Michigan, New York, Ohio, Tennessee, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Prostate Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00106392's enrollment target sits among peer trials
131 290th of 735 higher than 445 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer 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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