A Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Effect on Unassisted Erectile Function of the Early Use of Tadalafil 5 mg Once a Day and Tadalafil 20 mg On Demand Treatment for 9 Months in Subjects Undergoing Bilateral Nerve-Sparing Radical Prostatectomy - ND

• Conditions: nassisted Erectile Function in Subjects Undergoing Bilateral Nerve-Sparing Radical Prostatectomy; MedDRA version: 9.1Level: PTClassification code 10061461

• Registration Number: EUCTR2009-011850-17-IT
• Lead Sponsor: ELI LILLY

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10-28
• Last Update Posted: 18 March 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 690

Inclusion Criteria

Men may be considered for entry to the study if they: are scheduled to undergo BNSRP for organ-confined, non-metastatic prostate cancer; are aged >18 years at Visit 1 and <65 years at time of BNSRP; have a normal preoperative erectile function score (IIEF-EF score >=26 at Visit 1); and develop ED (defined as the consistent inability to achieve and/or maintain an erection sufficient to permit satisfactory sexual intercourse) after surgery. Surgeons performing the surgery must have sufficient prior experience, defined as at least 50 BNSRP surgical procedures performed before Visit 2. Female partners, if willing to participate by answering EPIC partner questions, must be aged >18 years at Visit 4, and anticipate having the same male study subject as her sexual partner during the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

[18] Have a history of ED, with or without treatment. 19] Have a history of prostatic surgery or prostatic physical treatments including hyperthermia, microwave therapy, transurethral needle ablation (TUNA), lasers, high intensity focused ultrasound (HIFU) and cryotherapy. [20] Have a history of penile implant. [21] Have a history of drug, alcohol or substance abuse within the previous 6 months, as assessed by the investigator. [22] Have a history of galactose intolerance, lapp lactase deficiency, or glucose-galactose malabsorption.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified