Evaluation of the Index of Sexual Life Questionnaire

NCT ID: NCT00245596

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

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Brief Summary

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The purpose of the study is to assess the sensibility of the ISL questionnaire.

Detailed Description

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Conditions

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Impotence

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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sildenafil

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

ED patient must:

* Be male, 18 years of age with no upper age limit;
* Have a documented clinical diagnosis of erectile dysfunction confirmed by an Erectile Function (IIEF) score 25. Erectile dysfunction is defined as "the inability to achieve and/or maintain an erection of the penis sufficient to permit satisfactory sexual performance" (Impotence-NIH Consensus Conference, JAMA 1993, 270: 83-90);
* Have a stable female partner for at least 6 months prior to screening.

Exclusion Criteria

* Have a known hypersensitivity to sildenafil or any component of the study medication; medical history of treatment-related intolerable side effects to sildenafil
* Be currently prescribed, taking and/or likely to be treated with nitrates or nitric oxide donors in any form on either a 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

Amphion-les-Bains, , France

Site Status

Pfizer Investigational Site

Bordeaux, , France

Site Status

Pfizer Investigational Site

La Rochelle, , France

Site Status

Pfizer Investigational Site

Lille, , France

Site Status

Pfizer Investigational Site

Lyon, , France

Site Status

Pfizer Investigational Site

Paris, , France

Site Status

Pfizer Investigational Site

Saint-Émilion, , France

Site Status

Pfizer Investigational Site

Thionville, , France

Site Status

Pfizer Investigational Site

Toulouse, , France

Site Status

Countries

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France

Related Links

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Other Identifiers

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A1481210

Identifier Type: -

Identifier Source: org_study_id

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