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A Study for Patients With Erectile Dysfunction to Test Whether Tadalafil Taken Once a Day Can Better Improve Psychological Outcomes.

NCT ID: NCT00734604

Last Updated: 2010-11-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

378 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2009-09-30

Brief Summary

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The primary purpose of the study is to help answer whether tadalafil taken once a day can help improve the psychological outcomes (such as sexual self confidence, spontaneity and time concerns) compared to sildenafil taken as needed in patients with erectile dysfunction (ED).

Detailed Description

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Conditions

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Erectile Dysfunction

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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T(OaD)/S(PRN)/T(PRN)

Tadalafil 5 mg once a day \[T(OaD)\] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed \[S(PRN)\] for 8 weeks, 1 week washout, tadalafil 20 mg as needed \[T(PRN)\] for 8 weeks

Group Type EXPERIMENTAL

tadalafil once a day [T(OaD)]

Intervention Type DRUG

5 mg tablet taken once a day (OaD) by mouth for 8 weeks

sildenafil citrate as needed [S(PRN)]

Intervention Type DRUG

100 mg tablet taken as needed (PRN) by mouth for 8 weeks

tadalafil as needed [T(PRN)]

Intervention Type DRUG

20 mg tablet taken as needed (PRN) by mouth for 8 weeks

T(OaD)/T(PRN)/S(PRN)

Tadalafil 5 mg once a day \[T(OaD)\] for 8 weeks, 1 week washout, tadalafil 20 mg as needed \[T(PRN)\] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed \[S(PRN)\] for 8 weeks

Group Type EXPERIMENTAL

tadalafil once a day [T(OaD)]

Intervention Type DRUG

5 mg tablet taken once a day (OaD) by mouth for 8 weeks

sildenafil citrate as needed [S(PRN)]

Intervention Type DRUG

100 mg tablet taken as needed (PRN) by mouth for 8 weeks

tadalafil as needed [T(PRN)]

Intervention Type DRUG

20 mg tablet taken as needed (PRN) by mouth for 8 weeks

S(PRN)/T(OaD)/T(PRN)

Sildenafil citrate 100 mg as needed \[S(PRN)\] for 8 weeks, 1 week washout, tadalafil 5 mg once a day \[T(OaD)\] for 8 weeks, 1 week washout, tadalafil 20 mg as needed \[T(PRN)\] for 8 weeks

Group Type EXPERIMENTAL

tadalafil once a day [T(OaD)]

Intervention Type DRUG

5 mg tablet taken once a day (OaD) by mouth for 8 weeks

sildenafil citrate as needed [S(PRN)]

Intervention Type DRUG

100 mg tablet taken as needed (PRN) by mouth for 8 weeks

tadalafil as needed [T(PRN)]

Intervention Type DRUG

20 mg tablet taken as needed (PRN) by mouth for 8 weeks

S(PRN)/T(PRN)/T(OaD)

Sildenafil citrate 100 mg as needed \[S(PRN)\] for 8 weeks, 1 week washout, tadalafil 20 mg as needed \[T(PRN)\] for 8 weeks, 1 week washout, tadalafil 5 mg once a day \[T(OaD)\] for 8 weeks

Group Type EXPERIMENTAL

tadalafil once a day [T(OaD)]

Intervention Type DRUG

5 mg tablet taken once a day (OaD) by mouth for 8 weeks

sildenafil citrate as needed [S(PRN)]

Intervention Type DRUG

100 mg tablet taken as needed (PRN) by mouth for 8 weeks

tadalafil as needed [T(PRN)]

Intervention Type DRUG

20 mg tablet taken as needed (PRN) by mouth for 8 weeks

T(PRN)/T(OaD)/S(PRN)

Tadalafil 20 mg as needed \[T(PRN)\] for 8 weeks, 1 week washout, tadalafil 5 mg once a day \[T(OaD)\] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed \[S(PRN)\] for 8 weeks

Group Type EXPERIMENTAL

tadalafil once a day [T(OaD)]

Intervention Type DRUG

5 mg tablet taken once a day (OaD) by mouth for 8 weeks

sildenafil citrate as needed [S(PRN)]

Intervention Type DRUG

100 mg tablet taken as needed (PRN) by mouth for 8 weeks

tadalafil as needed [T(PRN)]

Intervention Type DRUG

20 mg tablet taken as needed (PRN) by mouth for 8 weeks

T(PRN)/S(PRN)/T(OaD)

Tadalafil 20 mg as needed \[T(PRN)\] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed \[S(PRN)\] for 8 weeks, 1 week washout, tadalafil 5 mg once a day \[T(OaD)\] for 8 weeks

Group Type EXPERIMENTAL

tadalafil once a day [T(OaD)]

Intervention Type DRUG

5 mg tablet taken once a day (OaD) by mouth for 8 weeks

sildenafil citrate as needed [S(PRN)]

Intervention Type DRUG

100 mg tablet taken as needed (PRN) by mouth for 8 weeks

tadalafil as needed [T(PRN)]

Intervention Type DRUG

20 mg tablet taken as needed (PRN) by mouth for 8 weeks

Interventions

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tadalafil once a day [T(OaD)]

5 mg tablet taken once a day (OaD) by mouth for 8 weeks

Intervention Type DRUG

sildenafil citrate as needed [S(PRN)]

100 mg tablet taken as needed (PRN) by mouth for 8 weeks

Intervention Type DRUG

tadalafil as needed [T(PRN)]

20 mg tablet taken as needed (PRN) by mouth for 8 weeks

Intervention Type DRUG

Other Intervention Names

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Cialis LY450190 Cialis LY450190

Eligibility Criteria

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Inclusion Criteria

* History of erectile dysfunction (ED).
* Have had satisfactory response to tadalafil, sildenafil citrate, or vardenafil HCl for a period of at least 6 months and expect frequent use (at least one dose per week, on average) when administered as needed.
* Have never used tadalafil 5 mg or 2.5 mg once a day therapy.
* Anticipate having the same adult female sexual partner willing to participate during the study.
* Agree to make at least four sexual intercourse attempts during the first four weeks of the study.
* Agree not to use any other treatment for ED (even herbal treatments) during the study.
* Agree to follow the directions given by the study doctor and staff about using the study drug.

Exclusion Criteria

* Have any other primary sexual disorders present or penile deformity.
* Have history of radical prostatectomy or penile implant.
* Have problems with your kidneys, liver, or nervous system.
* Have uncontrolled diabetes, as measured by a blood test for haemoglobin A1C greater than a value of 11%.
* Are being treated for heart disease with any drug that is called a nitrate (for example, nitroglycerin).
* Have chest pain (called unstable angina or angina) that requires treatment.
* Have heart disease that causes symptoms after you exert yourself.
* Have had any of the following in the past 90 days: Heart attack, also known as a myocardial infarction (MI); Heart bypass surgery (called coronary artery bypass graft surgery); Had a procedure to open up blood vessels in the heart known as angioplasty or stent placement (percutaneous coronary intervention).
* Have a history of loss of vision in one eye because of nonarteritic anterior ischemic optic neuropathy (NAION).
* Have retinitis pigmentosa.
* Have history of human immunodeficiency virus (HIV).
* Have very high or very low blood pressure (your study doctor will discuss the limits with you).
* Have had a stroke or a significant injury to your brain or spinal cord within the last 6 months.
* Have rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption Lactose intolerance.
* Have a scheduled or planned surgery requiring anaesthesia during the course of the study.
* Have a scheduled cataract surgery during the curse of the study.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Eli Lilly

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 Easter 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.

Huntsville, Alabama, United States

Site Status

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Newport Beach, California, United States

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Middlebury, Connecticut, United States

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Plantation, Florida, United States

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Knoxville, Tennessee, United States

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San Antonio, Texas, United States

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Federal Way, Washington, United States

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Adelaide, South Australia, Australia

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Malvern, Victoria, Australia

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Nedlands, Western Australia, Australia

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Goiânia, , Brazil

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Rio Claro, , Brazil

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Rio de Janeiro, , Brazil

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Sao Jose Rio Preto, , Brazil

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São Paulo, , Brazil

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Augsburg, , Germany

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Berlin, , Germany

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Hamburg, , Germany

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Milan, , Italy

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Sassari, , Italy

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Torino, , Italy

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La Joya, , Mexico

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Mexico City, , Mexico

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Monterrey, , Mexico

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San Juan, , Puerto Rico

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Santurce, , Puerto Rico

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A Coruña, , Spain

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Barcelona, , Spain

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Madrid, , Spain

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Málaga, , Spain

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Seville, , Spain

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Vigo, , Spain

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Durham, County Durham, United Kingdom

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Plymouth, Devonshire, United Kingdom

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Lichfield, Staffordshire, United Kingdom

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Leeds, West Yorkshire, United Kingdom

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London, , United Kingdom

Site Status

Countries

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United States Australia Brazil Germany Italy Mexico Puerto Rico Spain United Kingdom

References

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Rubio-Aurioles E, Porst H, Kim ED, Montorsi F, Hackett G, Morales AM, Stuckey B, Buttner H, West TM, Huynh NN, Lenero E, Burns P, Kopernicky V. A randomized open-label trial with a crossover comparison of sexual self-confidence and other treatment outcomes following tadalafil once a day vs. tadalafil or sildenafil on-demand in men with erectile dysfunction. J Sex Med. 2012 May;9(5):1418-29. doi: 10.1111/j.1743-6109.2012.02667.x. Epub 2012 Mar 16.

Reference Type DERIVED
PMID: 22429760 (View on PubMed)

Other Identifiers

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H6D-CR-S024

Identifier Type: OTHER

Identifier Source: secondary_id

12313

Identifier Type: -

Identifier Source: org_study_id