At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 131 enrolled
Drug / intervention
Tacrolimus +1 moredrug
Likely dose
Not stated in record
Key inclusion· 1
- ✓Male scheduled to undergo bilateral nerve-sparing radical prostatectomy for prostate cancer
Key exclusion· 3
- ✕Age > 65 years
- ✕Type 1 or Type 2 diabetes diagnosis
- ✕Active daily smoking
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Prograf (Tacrolimus, FK 506) for the Prevention of Erectile Dysfunction Following Bilateral Nerve-sparing Radical Prostatectomy
In Brief
A Phase 4 clinical trial evaluating Tacrolimus and Placebo for Erectile Dysfunction and Prostate Cancer. Completed, enrolled 131 participants across 6 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsErectile Dysfunction, Prostate Cancer
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2005
First PostedMar 2005
Primary CompletionApr 2008
Study CompletionNov 2008
TodayJul 2026
First PostedMar 24, 2005
Enrollment StartFeb 1, 2005
Primary CompletionApr 1, 2008
Study CompletionNov 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 21.3 years ago
Interventions
Tacrolimusdrug
oral
Placebodrug
oral