Evaluation of the Index of Sexual Life Questionnaire

Phase 4CompletedNCT00245596

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.120 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Impotence

Interventions

sildenafilDRUG

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (9)

Pfizer Investigational Site

Amphion-les-Bains, France

Pfizer Investigational Site

Bordeaux, France

Pfizer Investigational Site

La Rochelle, France

Pfizer Investigational Site

Lille, France

Outcomes

Primary Outcomes

Treatment responsiveness of a new quality of sexual life questionnaire for female partners of men with erectile dysfunction.

Secondary Outcomes

The correlation between ED patients' partner quality of sexual life changes and patient's efficacy measures and these changes and patient reported outcomes of self-esteem

Data from ClinicalTrials.gov

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