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

Purpose

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).

Condition	Intervention	Phase
Impotence	Drug: Sildenafil Citrate	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Erectile Dysfunction

Drug Information available for: Sodium citrate Sildenafil Sildenafil citrate

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

The primary endpoint is the change from baseline to Visit 4 (Week 8) in the IIEF Erectile Function (EF) domain score.

Secondary Outcome Measures:

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

Estimated Enrollment:	312
Study Start Date:	November 2005
Estimated Study Completion Date:	September 2006

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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].

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00245258

Locations

Korea, Republic of
Pfizer Investigational Site
Pusan, Korea, Republic of, 602-739
Pfizer Investigational Site
Seoul, Korea, Republic of, 135-710
Pfizer Investigational Site
Seoul, Korea, Republic of, 136-705
Pfizer Investigational Site
Seoul, Korea, Republic of, 138-736
Pfizer Investigational Site
Seoul, Korea, Republic of, 110-744
Pfizer Investigational Site
Seoul, Korea, Republic of, 158-710
Russian Federation
Pfizer Investigational Site
St. Petersburg, Russia, Russian Federation
Pfizer Investigational Site
Moscow, Russian Federation, 125101
Pfizer Investigational Site
Moscow, Russian Federation, 105425
Pfizer Investigational Site
Moscow, Russian Federation, 117036
Pfizer Investigational Site
Rostov-on-Don, Russian Federation, 344022
Spain
Pfizer Investigational Site
Santander, Cantabria, Spain, 39008
Pfizer Investigational Site
Barcelona, Spain, 08035
Pfizer Investigational Site
Madrid, Spain, 28046
Pfizer Investigational Site
Sevilla, Spain, 41014
Sweden
Pfizer Investigational Site
Karlshamn, Sweden, 374 35
Pfizer Investigational Site
Malmo, Sweden, 205 02
Pfizer Investigational Site
Skovde, Sweden, 541 31
Pfizer Investigational Site
Stockholm, Sweden, 171 76

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Claes HI, 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):2184-91. Epub 2010 Apr 1.

Loran OB, Ströberg 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.

ClinicalTrials.gov Identifier:	NCT00245258 History of Changes
Other Study ID Numbers:	A1481239
Study First Received:	October 25, 2005
Last Updated:	October 5, 2006
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Sildenafil
Vasodilator Agents

Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013