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Sponsored by: |
Johns Hopkins University |
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Information provided by: | Johns Hopkins University |
ClinicalTrials.gov Identifier: | NCT00511498 |
The ability of sildenafil to aid in the return of erections after nerve-sparing radical prostatectomy has been established. Patients who had either one or both neurovascular bundles spared demonstrated dramatically better responses to "as needed" sildenafil than those that did not, and a positive erectile response to sildenafil was only seen in patients in whom at least one NVB was spared. This study has been designed to determine if sildenafil taken nightly works better than sildenafil on as "as needed" basis for the return of erectile function. The investigators hypothesis is that sildenafil taken nightly promotes a more rapid return of erectile function after nerve-sparing laparoscopic radical prostatectomy.
Condition | Intervention |
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Prostate Cancer |
Drug: Sildenafil |
Study Type: | Interventional |
Study Design: | Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Effect of Nightly Versus Prn Sildenafil on Early Return of Erectile Function Following Nerve-Sparing Laparoscopic Radical Prostatectomy |
Enrollment: | 100 |
Study Start Date: | March 2006 |
Study Completion Date: | October 2008 |
Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Placebo Arm: Placebo Comparator
Placebo nightly
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Drug: Sildenafil
50 mg daily at bedtime
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Drug: Active Comparator
Sildenafil 50mg nightly
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Drug: Sildenafil
50 mg daily at bedtime
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Ages Eligible for Study: | 18 Years to 64 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Maryland | |
Johns Hopkins Bayview Medical Center | |
Baltimore, Maryland, United States, 21224 |
Principal Investigator: | Christian P Pavlovich, MD | Johns Hopkins University |
Responsible Party: | Johns Hopkins University ( Christian Pavlovich, M.D. ) |
Study ID Numbers: | NA_00001428 |
Study First Received: | August 3, 2007 |
Last Updated: | November 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00511498 |
Health Authority: | United States: Institutional Review Board |
Laparoscopic Radical Prostatectomy Nightly sildenafil |
Prostatic Diseases Genital Neoplasms, Male Sildenafil |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |
Vasodilator Agents Neoplasms Phosphodiesterase Inhibitors Neoplasms by Site Molecular Mechanisms of Pharmacological Action |
Therapeutic Uses Enzyme Inhibitors Cardiovascular Agents Pharmacologic Actions |