To Determine Effect and Safety of Tadalafil Taken by Men of Different Races and With Different Diseases When Needed for Erections

NCT ID: NCT00547417

Last Updated: 2007-10-22

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

PHASE3

Total Enrollment

1933 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-07-31

Study Completion Date

2004-03-31

Brief Summary

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To compare men of different races and those with diabetes or depression to white men that do not have diabetes or depression but also suffer from the inability to get or keep an erection.

Detailed Description

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Conditions

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Impotence

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

tadalafil

Group Type ACTIVE_COMPARATOR

tadalafil

Intervention Type DRUG

20 mg tadalafil tablet taken by mouth, as needed, no more than once a day, for 12 weeks.

Interventions

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tadalafil

20 mg tadalafil tablet taken by mouth, as needed, no more than once a day, for 12 weeks.

Intervention Type DRUG

Other Intervention Names

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LY450190 Cialis IC351

Eligibility Criteria

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Inclusion Criteria

* At least 3 months history of erectile dysfunction (ED)
* Anticipate a monogamous relationship with a female sexual partner
* Be able to make minimum required sexual intercourse attempts
* Abstain from using any other ED treatment

Exclusion Criteria

* Other primary sexual disorders
* History of penile implant or clinically significant penile deformity
* History or current nitrate use
* History of certain heart problems
* History of certain kidney problems
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.

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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H6D-MC-LVFN

Identifier Type: -

Identifier Source: secondary_id

7006

Identifier Type: -

Identifier Source: org_study_id