Study to Determine a Preference Between Sildenafil or Tadalafil Treatment for Problems Getting an Erection

NCT ID: NCT00547352

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

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2005-06-30

Brief Summary

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To determine if men with problems getting and keeping an erection prefer treatment with tadalafil or sildenafil.

Detailed Description

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Conditions

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Impotence

Study Design

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Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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1

sildenafil treatment for at least 10 weeks prior to a 1 week wash out

Group Type ACTIVE_COMPARATOR

sildenafil

Intervention Type DRUG

Current users of sildenafil citrate for a minimum of 6 weeks prior to visit 1 will continue with an individual dosage to be taken no more than once a day for an additional 4 weeks.

2

Tadalafil treatment for 8 weeks following the 1 week washout period.

Group Type ACTIVE_COMPARATOR

tadalafil

Intervention Type DRUG

20 mg tadalafil tablets taken by mouth, as needed, no more than once a day for 8 weeks.

Interventions

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tadalafil

20 mg tadalafil tablets taken by mouth, as needed, no more than once a day for 8 weeks.

Intervention Type DRUG

sildenafil

Current users of sildenafil citrate for a minimum of 6 weeks prior to visit 1 will continue with an individual dosage to be taken no more than once a day for an additional 4 weeks.

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
* Anticipate a monogamous female sexual relationship
* Abstain from other erection treatments throughout the study
* Currently use sildenafil

Exclusion Criteria

* Other primary sexual disorders
* History of radical prostatectomy or other pelvic surgery that affected being able to have an erection
* History of penile implant or clinically significant penile deformity.
* Nitrate use
* Certain heart 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.

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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H6D-KL-S002

Identifier Type: -

Identifier Source: secondary_id

9152

Identifier Type: -

Identifier Source: org_study_id