Can Tadalafil Maintain Erectile Function In Patients Treated With Radiotherapy For Prostate Cancer?
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|ClinicalTrials.gov Identifier: NCT00215631|
Recruitment Status : Terminated (slow recruitment)
First Posted : September 22, 2005
Last Update Posted : September 15, 2015
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer Erectile Dysfunction||Drug: tadalafil||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Study Start Date :||October 2005|
|Actual Study Completion Date :||November 2005|
- To assess the efficacy, and safety, of 20 mg tadalafil once every 2 days, in comparison with placebo, to maintain erectile function of patients undergoing external-beam radiotherapy for prostate cancer.
- Erectile function defined as the sum of questions 3 and 4 of the IIEF questionnaire every 3 months till the end of the study (at 3-6-12-24 months).
- Erectile function domain of the IIEF, defined as the sum of questions 1-5, and 15 of the IIEF questionnaire, questions 2 and 3 of the Sexual Encounter Profile (SEP), and responses to the other questions of the IIEF, at 3-6-12-24 months after initiation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00215631
|Erasmus MC-Daniel den Hoed Cancer|
|Rotterdam, Netherlands, 3008 AE|
|Principal Investigator:||Luca Incrocci, MD, PhD||Erasmus MC|