Effect of Tadalafil on the Quality of Life and Sexual Life in Erectile Dysfunction

NCT ID: NCT00422578

Last Updated: 2007-10-25

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

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2005-09-30

Brief Summary

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Study is a clinical study assessing the effect of oral tadalafil 10mg or 20 mg on psychosocial aspects and quality of life of erectile dysfunction patients and to compare tadalafil with previous oral erectile dysfunction medication. Study period is 13 weeks. Study patients fill in quality of life questionnaires and treatment satisfaction questionnaires.

Detailed Description

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Conditions

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Impotence Erectile Dysfunction

Keywords

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erectile dysfunction tadalafil

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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tadalafil

Intervention Type DRUG

Other Intervention Names

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LY450190 Cialis IC351

Eligibility Criteria

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Inclusion Criteria

* have a history of erectile dysfunction (defined as a consistent change in the quality of erection that adversely affects the patient's satisfaction with sexual intercourse)of at least 3 months duration
* have been using any oral prescription medication,but not tadalafil, for erectile dysfunction for a minimum period of 3 months before visit 1
* have responded to previous erectile dysfunction medication as assessed by the investigator

Exclusion Criteria

* exhibit evidence of clinically significant hepatobiliary disease (including jaundice) at visit 1
* receiving treatment with cancer chemotherapy
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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ICOS Corporation

INDUSTRY

Sponsor Role collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Principal Investigators

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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Tampere, , Finland

Site Status

Countries

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Finland

Other Identifiers

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9113

Identifier Type: -

Identifier Source: org_study_id

H6D-HL-LVGD

Identifier Type: -

Identifier Source: secondary_id