Study to Evaluate Viagra's Ability to Provide a Better Sexual Experience Through Quality Erections and Satisfaction

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: October 25, 2005
Last updated: October 5, 2006
Last verified: October 2006

October 25, 2005
October 5, 2006
November 2005
Not Provided
The primary endpoint is the change from baseline to Visit 4 (Week 8) in the IIEF Erectile Function (EF) domain score.
Same as current
Complete list of historical versions of study NCT00245258 on Archive Site
The change from baseline to visit 6 (wk 12) in the IIEF-EF domain; the change from baseline to visit 4 (wk 8) and visit 6 (wk 12) in the domains and total score as well as the individual questions of the sexual experience questionnaire
Same as current
Not Provided
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Study to Evaluate Viagra's Ability to Provide a Better Sexual Experience Through Quality Erections and Satisfaction
A Multicenter, Double-Blind Placebo Controlled, Fixed Dose Study With An Open-Label, Flexible Dose Phase To Assess The Efficacy Of Sildenafil Citrate In Providing A Better Sexual Experience Including Quality Of Erections And Satisfaction In Men With Erectile Dysfunction

The study objective is to:

  1. To evaluate the effect of sildenafil citrate versus placebo on the IIEF_EF Domain at the end of the double-blind phase
  2. To assess the relationship between treatment with sildenafil citrate or placebo and responses to the Quality of Erection Questionnaire (QEQ) and Sexual Experience Questionnaire (SEX_Q).
Not Provided
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Drug: Sildenafil Citrate
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
September 2006
Not Provided

Inclusion Criteria:

  • Male subjects aged 18-65.
  • 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].
18 Years to 65 Years
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of,   Russian Federation,   Spain,   Sweden
Not Provided
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Study Director: Pfizer Call Center Pfizer
October 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP