Overview

A Study of Tadalafil After Radical Prostatectomy

Status:
Completed
Trial end date:
2012-10-01
Target enrollment:
Participant gender:
Summary
The study will include patients with localized prostate cancer who experience erectile dysfunction following bilateral nerve-sparing radical prostatectomy. Patients will be randomly assigned to three treatment arms: Tadalafil 5 mg once a day, Tadalafil 20 mg on demand (prior to anticipated sexual activity), and placebo. Patients will stay on therapy for 9 months and after withdrawal of medication for 6 weeks, patients will be evaluated for recovery of unassisted erectile function (without medication). An open-label extension for three months will evaluate the responsiveness of all patients to Tadalafil 5 mg once a day. Further objectives are to evaluate the treatment satisfaction of the respective therapies.
Phase:
Phase 4
Details
Lead Sponsor:
Eli Lilly and Company
Treatments:
Tadalafil