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Sponsored by: |
Erasmus Medical Center |
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Information provided by: | Erasmus Medical Center |
ClinicalTrials.gov Identifier: | NCT00215631 |
Because of the high incidence of post-radiation erectile dysfunction (ED), up to 72% after external-beam radiotherapy, this patient category represents a most difficult therapeutic challenge. Therefore, prevention of ED could be more effective than treatment. Tadalafil, a new phosphodiesterase type 5 inhibitor, has been recently introduced. No studies have investigated the efficacy of tadalafil in preventing ED in patients undergoing radiotherapy for prostate cancer. Efficacy of tadalafil can last up to 36 hours after intake. This will result in a prolonged and continuos enhancement of penile vascular responsiveness. This randomized, double-blind, placebo-controlled study has been designed to evaluate the efficacy of 20-mg of tadalafil administered for 12 months in maintaining erectile function of potent patients undergoing external-beam radiotherapy for prostate cancer.
Condition | Intervention | Phase |
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Prostate Cancer Erectile Dysfunction |
Drug: tadalafil |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Can Tadalafil (Cialis)® Maintain Erectile Function In Patients Treated With External-Beam Radiotherapy For Prostate Cancer? A Randomized, Double-Blind, Placebo-Controlled Study |
Estimated Enrollment: | 100 |
Study Start Date: | October 2005 |
Study Completion Date: | November 2005 |
It will be a double-blind, placebo-controlled, randomized trial. Patients scheduled for external-beam radiotherapy for prostate cancer will start using tadalafil 20 mg or placebo the first day of radiation. The blinded medication (active drug or placebo) has to be taken once every two days starting the day of the first radiation up to 12 months (52 weeks) after radiotherapy. The active drug or placebo may be taken at bedtime unrelated to sexual activity. In case of side effects the dose can be reduced to 10 mg. Erectile function will be assessed every 3 months up to 6 weeks (week 58) after discontinuation of drug treatment by using questions 3 and 4 of the International Index of Erectile Function (IIEF). Responders (maintained erectile function) are defined as having a combined score of >=8 for the IIEF questions 3 and 4.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | 2004-165 |
Study First Received: | September 18, 2005 |
Last Updated: | April 3, 2007 |
ClinicalTrials.gov Identifier: | NCT00215631 History of Changes |
Health Authority: | Netherlands: Medical Ethics Review Committee (METC) |
prostate cancer radiotherapy erectile dysfunction tadalafil |
Sexual Dysfunctions, Psychological Phosphodiesterase Inhibitors Sexual Dysfunction, Physiological Prostatic Diseases Genital Neoplasms, Male Mental Disorders |
Tadalafil Benzocaine Urogenital Neoplasms Genital Diseases, Male Erectile Dysfunction Prostatic Neoplasms |
Sexual Dysfunctions, Psychological Molecular Mechanisms of Pharmacological Action Genital Neoplasms, Male Prostatic Diseases Enzyme Inhibitors Urogenital Neoplasms Genital Diseases, Male Sexual and Gender Disorders Pharmacologic Actions |
Neoplasms Phosphodiesterase Inhibitors Neoplasms by Site Sexual Dysfunction, Physiological Mental Disorders Tadalafil Prostatic Neoplasms Erectile Dysfunction |