Study to Evaluate Viagra's Ability to Provide a Better Sexual Experience Through Quality Erections and Satisfaction
Information source: Pfizer
Information obtained from ClinicalTrials.gov on December 31, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Impotence
Intervention: Sildenafil Citrate (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Summary
The study objective is to:
To evaluate the effect of sildenafil citrate versus placebo on the IIEF_EF Domain at the end
of the double-blind phase
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).
Clinical Details
Official title: 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
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: The primary endpoint is the change from baseline to Visit 4 (Week 8) in the IIEF Erectile Function (EF) domain score.
Secondary outcome: 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
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Male.
Criteria:
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].
Locations and Contacts
Pfizer Investigational Site, Seoul 135-710, Korea, Republic of
Pfizer Investigational Site, Pusan 602-739, Korea, Republic of
Pfizer Investigational Site, Seoul 136-705, Korea, Republic of
Pfizer Investigational Site, Seoul 138-736, Korea, Republic of
Pfizer Investigational Site, Seoul 110-744, Korea, Republic of
Pfizer Investigational Site, Seoul 158-710, Korea, Republic of
Pfizer Investigational Site, Moscow 125101, Russian Federation
Pfizer Investigational Site, Moscow 105425, Russian Federation
Pfizer Investigational Site, Moscow 117036, Russian Federation
Pfizer Investigational Site, Rostov-on-Don 344022, Russian Federation
Pfizer Investigational Site, Barcelona 08035, Spain
Pfizer Investigational Site, MADRID 28046, Spain
Pfizer Investigational Site, Sevilla 41014, Spain
Pfizer Investigational Site, Stockholm 171 76, Sweden
Pfizer Investigational Site, Karlshamn 374 35, Sweden
Pfizer Investigational Site, Skovde 541 31, Sweden
Pfizer Investigational Site, Malmo 205 02, Sweden
Pfizer Investigational Site, Santander, Cantabria 39008, Spain
Pfizer Investigational Site, St. Petersburg, RUSSIA, Russian Federation
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: November 2005
Ending date: September 2006
Last updated: October 5, 2006
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