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

Last updated: October 21, 2010
Sponsor: Eli Lilly and Company
Overall Status: Completed

Phase

3

Condition

Erectile Dysfunction

Male Hormonal Deficiencies/abnormalities

Impotence

Treatment

N/A

Clinical Study ID

NCT00734604
12313
H6D-CR-S024
  • Ages > 18
  • Male

Study Summary

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • History of erectile dysfunction (ED).

  • Have had satisfactory response to tadalafil, sildenafil citrate, or vardenafil HCl fora period of at least 6 months and expect frequent use (at least one dose per week, onaverage) 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 duringthe study.

  • Agree to make at least four sexual intercourse attempts during the first four weeks ofthe 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 thestudy drug.

Exclusion

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 greaterthan a value of 11%.

  • Are being treated for heart disease with any drug that is called a nitrate (forexample, 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 amyocardial infarction (MI); Heart bypass surgery (called coronary artery bypass graftsurgery); Had a procedure to open up blood vessels in the heart known as angioplastyor stent placement (percutaneous coronary intervention).

  • Have a history of loss of vision in one eye because of nonarteritic anterior ischemicoptic 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 limitswith 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 orglucose-galactose malabsorption Lactose intolerance.

  • Have a scheduled or planned surgery requiring anaesthesia during the course of thestudy.

  • Have a scheduled cataract surgery during the curse of the study.

Study Design

Total Participants: 378
Study Start date:
August 01, 2008
Estimated Completion Date:
September 30, 2009

Connect with a study center

  • 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.

    Adelaide, South Australia 5000
    Australia

    Site Not Available

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    Malvern, Victoria 3144
    Australia

    Site Not Available

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    Nedlands, Western Australia 6009
    Australia

    Site Not Available

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    Goiânia, 74110-020
    Brazil

    Site Not Available

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    Goiânia, 74110-020
    Brazil

    Site Not Available

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    Rio Claro, 13500-020
    Brazil

    Site Not Available

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    Rio De Janeiro, 20725-090
    Brazil

    Site Not Available

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    Sao Jose Rio Preto, 15090-000
    Brazil

    Site Not Available

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    Sao Paulo, 04044-060
    Brazil

    Site Not Available

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    Augsburg, 86150
    Germany

    Site Not Available

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    Berlin, 13465
    Germany

    Site Not Available

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    Hamburg, 20354
    Germany

    Site Not Available

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    Milan, 20132
    Italy

    Site Not Available

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    Sassari, 07100
    Italy

    Site Not Available

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    Torino, 10126
    Italy

    Site Not Available

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    La Joya, 14000
    Mexico

    Site Not Available

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    Mexico City, 10700
    Mexico

    Site Not Available

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    Monterrey, 64040
    Mexico

    Site Not Available

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    San Juan, 00912
    Puerto Rico

    Site Not Available

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    Santurce, 00907
    Puerto Rico

    Site Not Available

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    Barcelona, 08025
    Spain

    Site Not Available

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    La Coruña, 15006
    Spain

    Site Not Available

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    La Coruña, 15006
    Spain

    Site Not Available

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    Madrid, 28040
    Spain

    Site Not Available

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    Malaga, 29007
    Spain

    Site Not Available

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    Sevilla, 41013
    Spain

    Site Not Available

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    Vigo, 36211
    Spain

    Site Not Available

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    Durham, County Durham DH1 2QW
    United Kingdom

    Site Not Available

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    Plymouth, Devonshire PL6 8BX
    United Kingdom

    Site Not Available

  • 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.

    Lichfield, Staffordshire WS14 9JL
    United Kingdom

    Site Not Available

  • 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.

    Leeds, West Yorkshire LS9 7TF
    United Kingdom

    Site Not Available

  • 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.

    London, NW8 9NH
    United Kingdom

    Site Not Available

  • 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 35801
    United States

    Site Not Available

  • 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.

    Newport Beach, California 92660
    United States

    Site Not Available

  • 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.

    Middlebury, Connecticut 06762
    United States

    Site Not Available

  • 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.

    Plantation, Florida 33317
    United States

    Site Not Available

  • 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.

    Knoxville, Tennessee 37920
    United States

    Site Not Available

  • 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.

    San Antonio, Texas 78229
    United States

    Site Not Available

  • 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.

    Federal Way, Washington 98003
    United States

    Site Not Available

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