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
1 other identifier
interventional
312
4 countries
19
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2005
Shorter than P25 for phase_4
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 25, 2005
CompletedFirst Posted
Study publicly available on registry
October 27, 2005
CompletedStudy Start
First participant enrolled
November 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2006
CompletedFebruary 1, 2021
January 1, 2021
October 25, 2005
January 28, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
The primary endpoint is the change from baseline to Visit 4 (Week 8) in the IIEF Erectile Function (EF) domain score.
Secondary Outcomes (1)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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.)
You may not qualify if:
- 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 \[Note: subjects should not have taken any PDE-5 inhibitors within 4 weeks prior to the date of screening\].
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Pfizer Investigational Site
Moscow, 105425, Russia
Pfizer Investigational Site
Moscow, 117036, Russia
Pfizer Investigational Site
Moscow, 125101, Russia
Pfizer Investigational Site
Rostov-on-Don, 344022, Russia
Pfizer Investigational Site
Saint Petersburg, Russia
Pfizer Investigational Site
Pusan, 602-739, South Korea
Pfizer Investigational Site
Seoul, 110-744, South Korea
Pfizer Investigational Site
Seoul, 135-710, South Korea
Pfizer Investigational Site
Seoul, 136-705, South Korea
Pfizer Investigational Site
Seoul, 138-736, South Korea
Pfizer Investigational Site
Seoul, 158-710, South Korea
Pfizer Investigational Site
Santander, Cantabria, 39008, Spain
Pfizer Investigational Site
Barcelona, 08035, Spain
Pfizer Investigational Site
Madrid, 28046, Spain
Pfizer Investigational Site
Seville, 41014, Spain
Pfizer Investigational Site
Karlshamn, 374 35, Sweden
Pfizer Investigational Site
Malmo, 205 02, Sweden
Pfizer Investigational Site
Skövde, 541 31, Sweden
Pfizer Investigational Site
Stockholm, 171 76, Sweden
Related Publications (4)
Cappelleri JC, Tseng LJ, Stecher V, Goldstein I. Enriching the Interpretation of the Erectile Dysfunction Inventory of Treatment Satisfaction: Characterizing Success in Treatment Satisfaction. J Sex Med. 2018 May;15(5):732-740. doi: 10.1016/j.jsxm.2018.03.078.
PMID: 29699758DERIVEDKirby M, Creanga DL, Stecher VJ. Erectile function, erection hardness and tolerability in men treated with sildenafil 100 mg vs. 50 mg for erectile dysfunction. Int J Clin Pract. 2013 Oct;67(10):1034-9. doi: 10.1111/ijcp.12229.
PMID: 24073975DERIVEDClaes HIM, Goldstein I, Althof SE, Berner MM, Cappelleri JC, Bushmakin AG, Symonds T, Schnetzler G. Understanding the effects of sildenafil treatment on erection maintenance and erection hardness. J Sex Med. 2010 Jun;7(6):2184-2191. doi: 10.1111/j.1743-6109.2010.01791.x. Epub 2010 Apr 1.
PMID: 20384942DERIVEDLoran OB, Stroberg P, Lee SW, Park NC, Kim SW, Tseng LJ, Collins S, Stecher VJ. Sildenafil citrate 100 mg starting dose in men with erectile dysfunction in an international, double-blind, placebo-controlled study: effect on the sexual experience and reducing feelings of anxiety about the next intercourse attempt. J Sex Med. 2009 Oct;6(10):2826-35. doi: 10.1111/j.1743-6109.2009.01428.x.
PMID: 19817982DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2005
First Posted
October 27, 2005
Study Start
November 1, 2005
Study Completion
September 1, 2006
Last Updated
February 1, 2021
Record last verified: 2021-01