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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00249730
Other study ID # A1481237
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date October 2005

Study information

Verified date January 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 510
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Sildenafil


Locations

Country Name City State
Canada Pfizer Investigational Site Kitchener Ontario
Canada Pfizer Investigational Site Sarnia Ontario
Canada Pfizer Investigational Site St. Leonard Quebec
Canada Pfizer Investigational Site Toronto Ontario
Canada Pfizer Investigational Site Trois-Rivieres Quebec
France Pfizer Investigational Site Lille
France Pfizer Investigational Site LYON Cedex 03
France Pfizer Investigational Site Montpellier
France Pfizer Investigational Site PARIS cedex 18
Greece Pfizer Investigational Site Goudi Athens
Greece Pfizer Investigational Site Patras
Greece Pfizer Investigational Site Thessaloniki
Israel Pfizer Investigational Site Beer Sheba
Israel Pfizer Investigational Site Haifa
Israel Pfizer Investigational Site Petach Tikva
Israel Pfizer Investigational Site Tel- Aviv
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
Russian Federation Pfizer Investigational Site Moscow
Spain Pfizer Investigational Site Alicante
Spain Pfizer Investigational Site Barcelona
Spain Pfizer Investigational Site La Laguna Santa Cruz De Tenerife
Spain Pfizer Investigational Site Madrid
Spain Pfizer Investigational Site Malaga
Spain Pfizer Investigational Site Sevilla
Spain Pfizer Investigational Site Valencia
United Kingdom Pfizer Investigational Site Ashford Middlesex
United Kingdom Pfizer Investigational Site Bath
United Kingdom Pfizer Investigational Site Belmont Durham
United Kingdom Pfizer Investigational Site Chippenham Wilts.
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 Pfizer Investigational Site Trowbridge Wiltshire
United Kingdom Pfizer Investigational Site Weybridge Surrey

Sponsors (1)

Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Countries where clinical trial is conducted

Canada,  France,  Greece,  Israel,  Italy,  Russian Federation,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in IIEF erectile function domain score at the end of double blind treatment.
Secondary Change in other IIEF domain scores; Response to other questionnaires regarding treatment satisfaction, safety and tolerability.
See also
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Completed NCT00882934 - The Management of Erectile Dysfunction With Placebo Only N/A
Withdrawn NCT00382161 - Improvement of Erectile Dysfunction by Fluvastatin in Patients With Cardiovascular Risk Factors Phase 3
Recruiting NCT00297544 - Effect of Sildenafil on Endothelial Function N/A
Completed NCT00245596 - Evaluation of the Index of Sexual Life Questionnaire Phase 4
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Completed NCT00547183 - Study the Safety and Effectiveness of Tadalafil in Men With Diabetes Who Have Problems Getting and Keeping an Erection Phase 3
Completed NCT00547092 - Study For Which Treatment, Tadalafil or Sildenafil, is Preferred For Problems Getting or Maintaining an Erection Phase 4
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Completed NCT00245258 - Study to Evaluate Viagra's Ability to Provide a Better Sexual Experience Through Quality Erections and Satisfaction Phase 4
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Completed NCT00147628 - Assessment Of Sildenafil On Erectile Function And Intercourse Satisfaction And To Validate A New Subject Questionnaire Phase 4
Completed NCT00547287 - Studying the Preference of Tadalafil to Sildenafil in Men With Problems Getting an Erection Across Nations Phase 3
Completed NCT03830164 - Pentoxifylline, Atorvastatin, and Vitamin E in Treating Patients With Erectile Dysfunction After Radiation Therapy for Prostate Cancer Phase 2
Recruiting NCT00498680 - Safety and Clinical Effectiveness of 2 Lower Dose Combined PDE5i's vs. Single Maximal Dose PDE5i Phase 4
Completed NCT00150358 - To Yield Further Information On The Efficacy And Safety Of Viagra Among Subjects With Arterial Hypertension . Phase 4
Completed NCT00159809 - Efficacy Study Measuring The Impact Of Treatment With Viagra On The Depressive Symptoms Of Men With Erectile Dysfunction Phase 4
Completed NCT00143221 - Effectiveness and Safety of Viagra in Men With ED and LUTS Due to Benign Prostatic Hyperplasia (BPH) Phase 4