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

Sponsor:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00734604

Purpose

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.

Condition	Intervention	Phase
Erectile Dysfunction	Drug: tadalafil Drug: sildenafil citrate	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study
Official Title:	A Comparison of Psychosocial Outcomes Following Tadalafil Once a Day or PDE5 Inhibitor As Needed in Men With Erectile Dysfunction.

Resource links provided by NLM:

MedlinePlus related topics: Erectile Dysfunction

Drug Information available for: Sildenafil Tadalafil Sildenafil citrate

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Change in Sexual Self-Confidence domain of Psychological and Interpersonal Relationship Scales (PAIRS). [ Time Frame: 26 weeks (including two washout periods of 1 week each) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Psychosocial outcomes, as measured by Sexual Self-Confidence, Spontaneity, and Time Concerns domains of PAIRS. [ Time Frame: 26 weeks (including two washout periods of 1 week each) ] [ Designated as safety issue: No ]
Efficacy, as measured by the Erectile Function domain (sum of Items 1 through 5 and Item 15) of the International Index of Erectile Function (IIEF) and the frequency of morning erection. [ Time Frame: 26 weeks (including two washout periods of 1 week each) ] [ Designated as safety issue: No ]
Sexual satisfaction, as measured by the Intercourse Satisfaction and Overall Satisfaction domains of the IIEF. [ Time Frame: 26 weeks (including two washout periods of 1 week each) ] [ Designated as safety issue: No ]
Treatment satisfaction, as measured by the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS). [ Time Frame: 26 weeks (including two washout periods of 1 week each) ] [ Designated as safety issue: No ]
Safety and tolerability. [ Time Frame: 26 weeks (including two washout periods of 1 week each) ] [ Designated as safety issue: Yes ]
Psychosocial outcomes, as measured by the Self-Esteem And Relationship (SEAR) questionnaire; and Questions 1 to 4 of the Patient Perception and Feelings Questions (PPF-Q). [ Time Frame: 26 weeks (including two washout periods of 1 week each) ] [ Designated as safety issue: No ]

Enrollment:	377
Study Start Date:	August 2008
Study Completion Date:	September 2009
Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Tadalafil 5 mg OaD, sildenafil citrate 100 mg PRN, tadalafil 20 mg PRN	Drug: tadalafil 5mg tablet taken once a day by mouth for 8 weeks Drug: sildenafil citrate 100mg tablet taken as needed by mouth for 8 weeks Drug: tadalafil 20mg tablet taken as needed by mouth for 8 weeks
2: Experimental Tadalafil 5 mg OaD, tadalafil 20 mg PRN, sildenafil citrate 100 mg PRN	Drug: tadalafil 5mg tablet taken once a day by mouth for 8 weeks Drug: sildenafil citrate 100mg tablet taken as needed by mouth for 8 weeks Drug: tadalafil 20mg tablet taken as needed by mouth for 8 weeks
3: Experimental Sildenafil citrate 100 mg PRN, tadalafil 5 mg OaD, tadalafil 20 mg PRN	Drug: tadalafil 5mg tablet taken once a day by mouth for 8 weeks Drug: sildenafil citrate 100mg tablet taken as needed by mouth for 8 weeks Drug: tadalafil 20mg tablet taken as needed by mouth for 8 weeks
4: Experimental Sildenafil citrate 100 mg PRN, tadalafil 20 mg PRN, tadalafil 5 mg OaD	Drug: tadalafil 5mg tablet taken once a day by mouth for 8 weeks Drug: sildenafil citrate 100mg tablet taken as needed by mouth for 8 weeks Drug: tadalafil 20mg tablet taken as needed by mouth for 8 weeks
5: Experimental Tadalafil 20 mg PRN, tadalafil 5 mg OaD, sildenafil citrate 100 mg PRN	Drug: tadalafil 5mg tablet taken once a day by mouth for 8 weeks Drug: sildenafil citrate 100mg tablet taken as needed by mouth for 8 weeks Drug: tadalafil 20mg tablet taken as needed by mouth for 8 weeks
6: Experimental Tadalafil 20 mg PRN, sildenafil citrate 100 mg PRN, tadalafil 5 mg OaD	Drug: tadalafil 5mg tablet taken once a day by mouth for 8 weeks Drug: sildenafil citrate 100mg tablet taken as needed by mouth for 8 weeks Drug: tadalafil 20mg tablet taken as needed by mouth for 8 weeks

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

History of erectile dysfunction.
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 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00734604

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Locations

United States, Alabama
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Huntsville, Alabama, United States, 35801
United States, California
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Newport Beach, California, United States, 92660
United States, Connecticut
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Middlebury, Connecticut, United States, 06762
United States, Florida
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Plantation, Florida, United States, 33317
United States, Tennessee
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Knoxville, Tennessee, United States, 37920
United States, Texas
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San Antonio, Texas, United States, 78229
United States, Washington
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Federal Way, Washington, United States, 98003
Australia, South Australia
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Adelaide, South Australia, Australia, 5000
Australia, Victoria
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Malvern, Victoria, Australia, 3144
Australia, Western Australia
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Nedlands, Western Australia, Australia, 6009
Brazil
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Goiânia, Brazil, 74110-020
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Rio Claro, Brazil, 13500-020
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Rio De Janeiro, Brazil, 20725-090
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Sao Paulo, Brazil, 04044-060
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Sao Jose Rio Preto, Brazil, 15090-000
Germany
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Augsburg, Germany, 86150
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Berlin, Germany, 13465
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Hamburg, Germany, 20354
Italy
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Milan, Italy, 20132
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Sassari, Italy, 07100
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Torino, Italy, 10126
Mexico
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La Joya, Mexico, 14000
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Mexico City, Mexico, 10700
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Monterrey, Mexico, 64040
Puerto Rico
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San Juan, Puerto Rico, 00912
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Santurce, Puerto Rico, 00907
Spain
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Barcelona, Spain, 08025
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La Coruña, Spain, 15006
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Madrid, Spain, 28040
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Malaga, Spain, 29007
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Sevilla, Spain, 41013
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Vigo, Spain, 36211
United Kingdom
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London, United Kingdom, NW8 9NH
United Kingdom, County Durham
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Durham, County Durham, United Kingdom, DH1 2QW
United Kingdom, Devonshire
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Plymouth, Devonshire, United Kingdom, PL6 8BX
United Kingdom, Staffordshire
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Lichfield, Staffordshire, United Kingdom, WS14 9JL
United Kingdom, West Yorkshire
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Leeds, West Yorkshire, United Kingdom, LS9 7TF

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director:

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)

Eli Lilly and Company

Responsible Party:	Eli Lilly ( Chief Medical Officer )
Study ID Numbers:	12313, H6D-CR-S024
Study First Received:	August 12, 2008
Last Updated:	October 1, 2009
ClinicalTrials.gov Identifier:	NCT00734604 History of Changes
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration; Brazil: Ministry of Health; Germany: Federal Institute for Drugs and Medical Devices; Italy: Ministry of Health; Mexico: Federal Commission for Sanitary Risks Protection; Mexico: Ethics Committee; Mexico: Ministry of Health; Spain: Ethics Committee; Spain: Spanish Agency of Medicines; United Kingdom: Medicines and Healthcare Products Regulatory Agency; United Kingdom: Research Ethics Committee; United States: Food and Drug Administration