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).

Condition	Intervention	Phase
Impotence	Drug: Sildenafil Citrate	Phase IV

Further Study Details: 

Primary Outcomes: Responses to Question 5 (erectile hardness) of the Event Log as measured from baseline to the end of double-blind treatment (week 6).
Secondary Outcomes: 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)
Expected Total Enrollment:  300

Ages Eligible for Study:  18 Years   -   55 Years,  Genders Eligible for Study:  Male

Criteria

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]

Please refer to this study by ClinicalTrials.gov identifier  NCT00159900

Pfizer CT.gov Call Center      1-800-718-1021 

Germany
      Pfizer Investigational Site, Muenchen,  81369,  Germany; Recruiting
      Pfizer Investigational Site, Starnberg,  82319,  Germany; Recruiting
      Pfizer Investigational Site, Muenchen,  81925,  Germany; Recruiting
Italy
      Pfizer Investigational Site, Firenze,  50139,  Italy; Recruiting
Poland
      Pfizer Investigational Site, Warszawa,  00-911,  Poland; Recruiting
      Pfizer Investigational Site, Lodz,  90-625,  Poland; Recruiting
      Pfizer Investigational Site, Lodz,  93-171,  Poland; Recruiting
      Pfizer Investigational Site, Lublin,  20-008,  Poland; Recruiting
      Pfizer Investigational Site, Szczecin,  71-240,  Poland; Recruiting
Turkey
      Pfizer Investigational Site, Istanbul,  34900,  Turkey; Recruiting
      Pfizer Investigational Site, Izmir,  35100,  Turkey; Recruiting
      Pfizer Investigational Site, Diyarbakir,  21280,  Turkey; Recruiting
      Pfizer Investigational Site, Bursa,  16070,  Turkey; Recruiting

Study chairs or principal investigators

Pfizer CT.gov Call Center,  Study Director,  Pfizer   

Study ID Numbers:  A1481222
Last Updated:  September 11, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00159900
Health Authority: Germany: Ethics Commission
ClinicalTrials.gov processed this record on 2005-09-13