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Study For Which Treatment, Tadalafil or Sildenafil, is Preferred For Problems Getting or Maintaining an Erection

NCT ID: NCT00547092

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

PHASE4

Total Enrollment

386 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2004-11-30

Brief Summary

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To determine if men prefer tadalafil or sildenafil for getting and keeping an erection after treatment with both drugs.

Detailed Description

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Conditions

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Impotence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

tadalafil given the first 12 weeks and after a 4 week washout sildenafil is given for 12 weeks.

Group Type ACTIVE_COMPARATOR

tadalafil

Intervention Type DRUG

10 mg or 20 mg tadalafil tablets, as needed, no more than once a day, by mouth for 12 weeks (8 week treatment experience phase and a 4 week treatment assessment phase)

2

sildenafil given the first 12 weeks and after a 4 week washout tadalafil is given for 12 weeks.

Group Type ACTIVE_COMPARATOR

sildenafil

Intervention Type DRUG

25 mg, 50 mg, or 100 mg sildenafil citrate tablets, as needed, no more than once a day, by mouth for 12 weeks (8 week treatment experience phase and a 4 week treatment assessment phase)

Interventions

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tadalafil

10 mg or 20 mg tadalafil tablets, as needed, no more than once a day, by mouth for 12 weeks (8 week treatment experience phase and a 4 week treatment assessment phase)

Intervention Type DRUG

sildenafil

25 mg, 50 mg, or 100 mg sildenafil citrate tablets, as needed, no more than once a day, by mouth for 12 weeks (8 week treatment experience phase and a 4 week treatment assessment phase)

Intervention Type DRUG

Other Intervention Names

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LY450190 Cialis IC351

Eligibility Criteria

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Inclusion Criteria

* History of erection problems
* Never taken treatments known as PDE5 inhibitors for erection issues
* Abstain from using any other erection treatments during the study
* Anticipate a monogamous female sexual relationship
* Must be able to make required sexual intercourse attempts

Exclusion Criteria

* History of other primary sexual disorder
* Treatment with nitrates
* Have a penile implant or clinically significant penile deformity
* History of certain heart problems
* Do not meet certain lab value reference ranges
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.

Plymouth, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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H6D-MC-LVFL

Identifier Type: -

Identifier Source: secondary_id

7002

Identifier Type: -

Identifier Source: org_study_id