Erectile Dysfunction Clinical Trial
Official title:
A Multicenter, Parallel Group Flexible Dose Study With A Double Blind, Randomized, Placebo Controlled Phase And An Open-Label Phase To Evaluate The Quality Of Erections In Men With Erectile Dysfunction Treated With Sildenafil Citrate
NCT number | NCT00159900 |
Other study ID # | A1481222 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | May 2005 |
Est. completion date | January 2006 |
Verified date | January 2021 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study objective is to evaluate the effect that sildenafil citrate has on the hardness of erections in males with erectile dysfunction, based on subject responses to question 5 on the Event Log (hardness of erection) as measured at the end of double blind treatment (week 6).
Status | Completed |
Enrollment | 300 |
Est. completion date | January 2006 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 55 Years |
Eligibility | Inclusion Criteria: - Male subjects aged 18-55 - Documented clinical diagnosis of erectile dysfunction confirmed by an IIEF-EF Domain score of less than or equal to 25. (If the subject scores greater than 25 on the IIEF-EF Domain, screening procedures should be terminated.) Exclusion Criteria: - Subjects who have been treated with more than 6 doses of sildenafil citrate or any other phosphodiesterase type 5 (PDE-5) inhibitor such as vardenafil or tadalafil for erectile dysfunction [Note: subjects should not have taken any PDE-5 inhibitors within 4 weeks prior to the date of screening] |
Country | Name | City | State |
---|---|---|---|
Brazil | Pfizer Investigational Site | Belo Horizonte | MG |
Brazil | Pfizer Investigational Site | Rio Claro | SP |
Brazil | Pfizer Investigational Site | Rio de Janeiro | RJ |
Brazil | Pfizer Investigational Site | Sao Paulo | SP |
Brazil | Pfizer Investigational Site | Sao Paulo | SP |
Germany | Pfizer Investigational Site | Frankfurt | |
Germany | Pfizer Investigational Site | Marburg | |
Germany | Pfizer Investigational Site | Muenchen | |
Germany | Pfizer Investigational Site | Muenchen | |
Germany | Pfizer Investigational Site | Rosenheim | |
Germany | Pfizer Investigational Site | Starnberg | |
Italy | Pfizer Investigational Site | Catania | |
Italy | Pfizer Investigational Site | Firenze | |
Italy | Pfizer Investigational Site | Roma | |
Poland | Pfizer Investigational Site | Lodz | |
Poland | Pfizer Investigational Site | Lodz | |
Poland | Pfizer Investigational Site | Lublin | |
Poland | Pfizer Investigational Site | Szczecin | |
Poland | Pfizer Investigational Site | Warszawa | |
Turkey | Pfizer Investigational Site | Bursa | |
Turkey | Pfizer Investigational Site | Diyarbakir | |
Turkey | Pfizer Investigational Site | Istanbul | |
Turkey | Pfizer Investigational Site | Izmir |
Lead Sponsor | Collaborator |
---|---|
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. |
Brazil, Germany, Italy, Poland, Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Responses to Question 5 (erectile hardness) of the Event Log as measured from baseline to the end of double-blind treatment (week 6). | |||
Secondary | Responses to the Quality of Erectile Questionnaire (QEQ) Responses to International Index of Erectile Function (IIEF) Domains (Erectile Function; Orgasmic Function; Sexual Desire; Intercourse Satisfaction; Overall Satisfaction) |
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