Titration Study to Evaluate Efficacy and Satisfaction of Viagra in Men With Erectile Function.

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00249730
First received: November 3, 2005
Last updated: December 18, 2006
Last verified: December 2006
  Purpose

To evaluate the efficacy of Viagra dose titration to 100mg versus 50mg in men with erectile dysfunction, based on responses to the IIEF questionnaire as measured at the beginning and at the end of double blind treatment, comparing the group titrated to 100mg vs. the group maintained on 50mg.


Condition Intervention Phase
Impotence
Drug: Sildenafil
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 Prospective Multicenter, Parallel Group Study With A Single Blind Phase And A Double Blind Randomised Phase, To Evaluate The Efficacy And Satisfaction Of Viagra (Sildenafil Citrate) High Dose (100mg) Titration Compared With 50mg Dose, In Men With Erectile Dysfunction

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change in IIEF erectile function domain score at the end of double blind treatment.

Secondary Outcome Measures:
  • Change in other IIEF domain scores; Response to other questionnaires regarding treatment satisfaction, safety and tolerability.

Estimated Enrollment: 510
Study Start Date: October 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documented clinical diagnosis of ED by using IIEF-EF domain with score of ≤ 25.
  • Subjects must be in a stable relationship with the same partner for at least 6 months and willing to attempt sexual intercourse.

Exclusion Criteria:

  • Subjects in whom sexual activity is inadvisable in the opinion of the investigator such as significant cardiovascular disease in the last 6 months; including cardiac failure, myocardial infarction, unstable angina, stroke or transient ischemic attack (TIA), symptomatic or clinically significant cardiac arrhythmias including atrial fibrillation.
  • Subjects who are currently taking or are likely to be treated with nitrates or nitric oxide donors in any form (oral, sublingual, buccal, transdermal, inhalational or as aerosols) on either regular or intermittent basis.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00249730

  Hide Study Locations
Locations
Canada, Ontario
Pfizer Investigational Site
Kitchener, Ontario, Canada
Pfizer Investigational Site
Sarnia, Ontario, Canada
Pfizer Investigational Site
Toronto, Ontario, Canada
Canada, Quebec
Pfizer Investigational Site
St. Leonard, Quebec, Canada
Pfizer Investigational Site
Trois-Rivieres, Quebec, Canada
France
Pfizer Investigational Site
Lille, France
Pfizer Investigational Site
LYON Cedex 03, France
Pfizer Investigational Site
Montpellier, France
Pfizer Investigational Site
PARIS cedex 18, France
Greece
Pfizer Investigational Site
Goudi, Athens, Greece
Pfizer Investigational Site
Patras, Greece
Pfizer Investigational Site
Thessaloniki, Greece
Israel
Pfizer Investigational Site
Beer Sheba, Israel
Pfizer Investigational Site
Haifa, Israel
Pfizer Investigational Site
Petach Tikva, Israel
Pfizer Investigational Site
Tel- Aviv, Israel
Italy
Pfizer Investigational Site
Bologna, Italy
Pfizer Investigational Site
Firenze, Italy
Pfizer Investigational Site
L'Aquila, Italy
Pfizer Investigational Site
Milano, Italy
Pfizer Investigational Site
Roma, Italy
Russian Federation
Pfizer Investigational Site
Moscow, Russian Federation
Spain
Pfizer Investigational Site
La Laguna, Santa Cruz de Tenerife, Spain
Pfizer Investigational Site
Alicante, Spain
Pfizer Investigational Site
Barcelona, Spain
Pfizer Investigational Site
Madrid, Spain
Pfizer Investigational Site
Malaga, Spain
Pfizer Investigational Site
Sevilla, Spain
Pfizer Investigational Site
Valencia, Spain
United Kingdom
Pfizer Investigational Site
Belmont, Durham, United Kingdom
Pfizer Investigational Site
Ashford, Middlesex, United Kingdom
Pfizer Investigational Site
Weybridge, Surrey, United Kingdom
Pfizer Investigational Site
Chippenham, Wilts., United Kingdom
Pfizer Investigational Site
Trowbridge, Wiltshire, United Kingdom
Pfizer Investigational Site
Bath, United Kingdom
Pfizer Investigational Site
Coventry, United Kingdom
Pfizer Investigational Site
Doncaster, United Kingdom
Pfizer Investigational Site
Dundee, United Kingdom
Pfizer Investigational Site
Glasgow, United Kingdom
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00249730     History of Changes
Other Study ID Numbers: A1481237
Study First Received: November 3, 2005
Last Updated: December 18, 2006
Health Authority: United Kingdom: National Health Service

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 April 21, 2014