Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00122499
Status:
COMPLETED
Last Update Posted:
2005-07-27
First Post:
2005-07-19
Brief Title:
A Study to Assess the Efficacy of Tadalafil to Treat Erectile Dysfunction After Radiotherapy of Prostate Cancer
Sponsor:
Erasmus Medical Center
Organization:
Erasmus Medical Center
Study Overview
Official Title:
A Study to Assess the Efficacy of Tadalafil to Treat Erectile Dysfunction After Radiotherapy of Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2005-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study has been designed to evaluate the efficacy and safety of a 20-mg dose of tadalafil administered on demand to patients with erectile dysfunction ED after external-beam radiotherapy EBRT of prostate cancer
Detailed Description:
Prostate cancer has become the most frequent malignancy in older men in Western countries Radiotherapy is a common treatment modality for early stage prostate cancer 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 Oral drug therapy represents the first-line management option for patients with ED The results of the studies completed thus far with sildenafil show that a phosphodiesterase type 5 inhibitor is a safe and efficacious drug for the treatment of post-radiation ED No studies have investigated the efficacy of tadalafil in men complaining of ED after radiotherapy of prostate cancer Because of the extended period of effectiveness which may last up to 36 hours after intake tadalafil allows freedom in the choice for time of sexual activity Also the absence of restrictions of tadalafil intake with food or alcohol should simplify its administration This randomized double-blind placebo-controlled cross-over study has been designed to evaluate the efficacy and safety of on demand dosing of 20-mg of tadalafil or placebo administered for 12 weeks to patients with ED after external-beam radiotherapy for prostate cancer
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None