A Safety and Efficacy Study of Prograf in the Prevention of Erectile Dysfunction After Radical Prostatectomy

Phase 4 Completed 131 enrolled Astellas Pharma Inc

RandomizedParallel-groupQuadruple-blindPrevention

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.

Timeline

Start: 2005-02
Primary completion: 2008-04
Completion: 2008-11

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Tacrolimus vs Placebo; p = 0.111; Wilcoxon (Mann-Whitney); note: P-Values were not adjusted. NCT00106392 ↗

paper Despite supportive animal data, tacrolimus used in this fashion in the RP population failed to demonstrate any superiority over placebo. PMID 30224019 ↗

Publications

Mulhall JP, Klein EA, Slawin K, Henning AK, Scardino PT. A Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Utility of Tacrolimus (FK506) for the Prevention of Erectile Dysfunction Following Bilateral Nerve-Sparing Radical Prostatectomy. J Sex Med. 2018 Sep;15(9):1293-1299. doi: 10.1016/j.jsxm.2018.07.009.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tacrolimus	Small molecule	3 mg	Oral