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

NCT ID: NCT00249730

Last Updated: 2021-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

510 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Impotence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Sildenafil

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Kitchener, Ontario, Canada

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Sarnia, Ontario, Canada

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Toronto, Ontario, Canada

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Saint-Léonard, Quebec, Canada

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Trois-Rivières, Quebec, Canada

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Lille, , France

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Lyon, , France

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Montpellier, , France

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Paris, , France

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Goudi, Athens, Greece

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Pátrai, , Greece

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Thessaloniki, , Greece

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Beersheba, , Israel

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Haifa, , Israel

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Petah Tikva, , Israel

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Tel Aviv, , Israel

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Bologna, , Italy

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Florence, , Italy

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

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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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Belmont, Durham, United Kingdom

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Ashford, Middlesex, United Kingdom

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Weybridge, Surrey, United Kingdom

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Chippenham, Wilts., United Kingdom

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Trowbridge, Wiltshire, United Kingdom

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Bath, , United Kingdom

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Coventry, , United Kingdom

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Doncaster, , United Kingdom

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Dundee, , United Kingdom

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Glasgow, , United Kingdom

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Countries

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Canada France Greece Israel Italy Russia Spain United Kingdom

Related Links

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Other Identifiers

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A1481237

Identifier Type: -

Identifier Source: org_study_id

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