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

NCT00249730 | Completed Phase 4

• 1 other identifier: A1481237
• Study Type: interventional
• Target: 510
• Locations: 8 countries
• Sites: 39

Brief 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.

Conditions

Impotence

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

Sildenafil DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Study Sites (39)

Pfizer Investigational Site

Kitchener, Ontario, Canada

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Pfizer Investigational Site

Sarnia, Ontario, Canada

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Pfizer Investigational Site

Toronto, Ontario, Canada

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Pfizer Investigational Site

Saint-Léonard, Quebec, Canada

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Pfizer Investigational Site

Trois-Rivières, Quebec, Canada

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Pfizer Investigational Site

Lille, France

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Lyon, France

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Pfizer Investigational Site

Montpellier, France

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Pfizer Investigational Site

Paris, France

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Pfizer Investigational Site

Goudi, Athens, Greece

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Pfizer Investigational Site

Pátrai, Greece

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Pfizer Investigational Site

Thessaloniki, Greece

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Pfizer Investigational Site

Beersheba, Israel

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Pfizer Investigational Site

Haifa, Israel

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Pfizer Investigational Site

Petah Tikva, Israel

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Pfizer Investigational Site

Tel Aviv, Israel

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Pfizer Investigational Site

Bologna, Italy

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Pfizer Investigational Site

Florence, Italy

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Pfizer Investigational Site

L’Aquila, Italy

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Milan, Italy

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Roma, Italy

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Moscow, Russia

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Pfizer Investigational Site

San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain

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Pfizer Investigational Site

Alicante, Spain

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Barcelona, Spain

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Madrid, Spain

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Málaga, Spain

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Seville, Spain

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Valencia, Spain

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Pfizer Investigational Site

Belmont, Durham, United Kingdom

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Pfizer Investigational Site

Ashford, Middlesex, United Kingdom

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Pfizer Investigational Site

Weybridge, Surrey, United Kingdom

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Pfizer Investigational Site

Chippenham, Wilts., United Kingdom

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Pfizer Investigational Site

Trowbridge, Wiltshire, United Kingdom

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Pfizer Investigational Site

Bath, United Kingdom

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Pfizer Investigational Site

Coventry, United Kingdom

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Pfizer Investigational Site

Doncaster, United Kingdom

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Pfizer Investigational Site

Dundee, United Kingdom

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Pfizer Investigational Site

Glasgow, United Kingdom

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Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

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: November 3, 2005
• First Posted: November 7, 2005
• Study Start: October 1, 2005
• Last Updated: February 1, 2021

Record last verified: 2021-01

Locations

GB (10); FR (4); RU (1); GR (3); ES (7); IT (5); IL (4); CA (5)