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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


Phase 4
18 Years
67 Years
Not Enrolling
Male
Erectile Dysfunction

Thank you

Trial Information

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


Inclusion Criteria:



- scheduled to undergo Bilateral nerve-sparing radical prostatectomy (BNSRP) for
organ-confined, non-metastatic prostate cancer

- have a normal preoperative erectile function score of more or equal to 22 at
screening(as evaluated by International Index of Erectile Function - Erectile
Function domain (IIEF-EF))

- develop Erectile Dysfunction (ED) (defined as the consistent inability to achieve
and/or maintain an erection sufficient to permit satisfactory sexual intercourse)
after surgery

- have an interest in resuming sexual activity as soon as possible after surgery and
anticipate having the same adult female sexual partner during the study

- agree not to use any other treatment for ED, including herbal and over-the-counter
(OTC) medications, during the study

- does not require the initiation of adjuvant therapy for prostate cancer

Exclusion Criteria:

- history of ED

- have received previous or current treatment with tadalafil or any other PDE5
(Phosphodiesterase Type 5) inhibitor

- have undergone, or plan to undergo, radiation or hormonal therapy for prostate cancer

- have a history of prostatic surgery or prostatic physical treatments

- have a history of diabetes mellitus

- have a history of galactose intolerance, lapp lactase deficiency, or
glucose-galactose malabsorption

- have clinically significant renal insufficiency as determined by the investigator

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Percentage of subjects with a score of greater than or equal to 22 in the Erectile Function (EF) Domain of the International Index of Erectile Function (IIEF) questionnaire

Outcome Time Frame:

Randomization to end of 6 weeks of study drug free washout

Safety Issue:

No

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

13086

NCT ID:

NCT01026818

Start Date:

November 2009

Completion Date:

October 2012

Related Keywords:

  • Erectile Dysfunction
  • Erectile Dysfunction
  • Radical Prostatectomy
  • Erectile Dysfunction

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