Quality of Erection Study

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00159900
First received: September 8, 2005
Last updated: April 4, 2008
Last verified: April 2008
  Purpose

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
Erectile Dysfunction
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, Parallel Group Flexible Dose Study With A Double Blind, Randomized, Placebo Controlled Phase And An Open-Label Phase To Evaluate The Quality Of Erections In Men With Erectile Dysfunction Treated With Sildenafil Citrate

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Responses to Question 5 (erectile hardness) of the Event Log as measured from baseline to the end of double-blind treatment (week 6).

Secondary Outcome Measures:
  • 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)

Estimated Enrollment: 300
Study Start Date: May 2005
Estimated Study Completion Date: January 2006
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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]
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00159900

Locations
Brazil
Pfizer Investigational Site
Belo Horizonte, MG, Brazil, 30130-008
Pfizer Investigational Site
Rio de Janeiro, RJ, Brazil, 20551-030
Pfizer Investigational Site
Rio Claro, SP, Brazil, 13500-020
Pfizer Investigational Site
Sao Paulo, SP, Brazil, 04044-060
Pfizer Investigational Site
Sao Paulo, SP, Brazil, 04262-000
Germany
Pfizer Investigational Site
Frankfurt, Germany, 65929
Pfizer Investigational Site
Marburg, Germany, 35039
Pfizer Investigational Site
Muenchen, Germany, 81369
Pfizer Investigational Site
Muenchen, Germany, 81925
Pfizer Investigational Site
Rosenheim, Germany, D 83022
Pfizer Investigational Site
Starnberg, Germany, 82319
Italy
Pfizer Investigational Site
Catania, Italy, 95124
Pfizer Investigational Site
Firenze, Italy, 50139
Pfizer Investigational Site
Roma, Italy, 00161
Poland
Pfizer Investigational Site
Lodz, Poland, 93-171
Pfizer Investigational Site
Lodz, Poland, 90-625
Pfizer Investigational Site
Lublin, Poland, 20-008
Pfizer Investigational Site
Szczecin, Poland, 71-240
Pfizer Investigational Site
Warszawa, Poland, 00-911
Turkey
Pfizer Investigational Site
Bursa, Turkey, 16070
Pfizer Investigational Site
Diyarbakir, Turkey, 21280
Pfizer Investigational Site
Istanbul, Turkey, 34900
Pfizer Investigational Site
Izmir, Turkey, 35100
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00159900     History of Changes
Other Study ID Numbers: A1481222
Study First Received: September 8, 2005
Last Updated: April 4, 2008
Health Authority: Germany: Ethics Commission

Keywords provided by Pfizer:
Impotence

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 July 26, 2014