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

ELI LILLY0 个研究点目标入组 690 人开始时间: 2009年10月28日最近更新: 2013年3月18日

适应症

试验速览

暂无简介。

•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

•[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.

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