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

A Comparison of Psychosocial Outcomes Following Tadalafil Once a Day or PDE5 Inhibitor As Needed in Men With Erectile Dysfunction.

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).

Study Overview

• Status: Completed
• Conditions: Erectile Dysfunction
• Intervention / Treatment: Drug: tadalafil once a day [T(OaD)]; Drug: sildenafil citrate as needed [S(PRN)]; Drug: tadalafil as needed [T(PRN)]

• Study Type: Interventional
• Enrollment (Actual): 378
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: tadalafil once a day [T(OaD)]; 5 mg tablet taken once a day (OaD) by mouth for 8 weeks; Other Names: LY450190; Cialis; Drug: sildenafil citrate as needed [S(PRN)]; 100 mg tablet taken as needed (PRN) by mouth for 8 weeks; Drug: tadalafil as needed [T(PRN)]; 20 mg tablet taken as needed (PRN) by mouth for 8 weeks; Other Names: LY450190; Cialis
Experimental: 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	Drug: tadalafil once a day [T(OaD)]; 5 mg tablet taken once a day (OaD) by mouth for 8 weeks; Other Names: LY450190; Cialis; Drug: sildenafil citrate as needed [S(PRN)]; 100 mg tablet taken as needed (PRN) by mouth for 8 weeks; Drug: tadalafil as needed [T(PRN)]; 20 mg tablet taken as needed (PRN) by mouth for 8 weeks; Other Names: LY450190; Cialis
Experimental: 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	Drug: tadalafil once a day [T(OaD)]; 5 mg tablet taken once a day (OaD) by mouth for 8 weeks; Other Names: LY450190; Cialis; Drug: sildenafil citrate as needed [S(PRN)]; 100 mg tablet taken as needed (PRN) by mouth for 8 weeks; Drug: tadalafil as needed [T(PRN)]; 20 mg tablet taken as needed (PRN) by mouth for 8 weeks; Other Names: LY450190; Cialis
Experimental: 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	Drug: tadalafil once a day [T(OaD)]; 5 mg tablet taken once a day (OaD) by mouth for 8 weeks; Other Names: LY450190; Cialis; Drug: sildenafil citrate as needed [S(PRN)]; 100 mg tablet taken as needed (PRN) by mouth for 8 weeks; Drug: tadalafil as needed [T(PRN)]; 20 mg tablet taken as needed (PRN) by mouth for 8 weeks; Other Names: LY450190; Cialis
Experimental: 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	Drug: tadalafil once a day [T(OaD)]; 5 mg tablet taken once a day (OaD) by mouth for 8 weeks; Other Names: LY450190; Cialis; Drug: sildenafil citrate as needed [S(PRN)]; 100 mg tablet taken as needed (PRN) by mouth for 8 weeks; Drug: tadalafil as needed [T(PRN)]; 20 mg tablet taken as needed (PRN) by mouth for 8 weeks; Other Names: LY450190; Cialis
Experimental: 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	Drug: tadalafil once a day [T(OaD)]; 5 mg tablet taken once a day (OaD) by mouth for 8 weeks; Other Names: LY450190; Cialis; Drug: sildenafil citrate as needed [S(PRN)]; 100 mg tablet taken as needed (PRN) by mouth for 8 weeks; Drug: tadalafil as needed [T(PRN)]; 20 mg tablet taken as needed (PRN) by mouth for 8 weeks; Other Names: LY450190; Cialis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline Between Tadalafil Once a Day (OaD) and Sildenafil as Needed (PRN) in Sexual Self-Confidence Domain of Psychological and Interpersonal Relationship Scales (PAIRS)	The PAIRS is a self-administed scale that assesses the broader psychological and interpersonal outcomes associated with erectile dysfunction and its treatment. Sexual Self-Confidence score is the average of responses on 6 PAIRS item scores. Sexual Self-Confidence scores range from 1 (strongly disagree) to 4 (strongly agree). Higher scores are indicative of greater sexual self-confidence.	baseline, 8 weeks of each treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline Between Tadalafil Once a Day (OaD) and Tadalafil as Needed (PRN) in Sexual Self-Confidence Domain of Psychological and Interpersonal Relationship Scales (PAIRS)	The PAIRS is a self-administed scale that assesses the broader psychological and interpersonal outcomes associated with erectile dysfunction and its treatment. Sexual Self-Confidence score is the average of responses on 6 PAIRS item scores. Sexual Self-Confidence scores range from 1 (strongly disagree) to 4 (strongly agree). Higher scores are indicative of greater sexual self-confidence.	baseline, 8 weeks of each treatment
Change From Baseline to Endpoint in the Spontaneity Domain of PAIRS	The PAIRS is a self-administed scale that assesses the broader psychological and interpersonal outcomes associated with erectile dysfunction and its treatment. Spontaneity score is the average of responses on 9 PAIRS item scores. Spontaneity scores range from 1 (strongly disagree) to 4 (strongly agree). Higher scores are indicative of greater spontaneity.	baseline, 8 weeks of each treatment
Change From Baseline to Endpoint in the Time Concerns Domain of PAIRS	The PAIRS is a self-administed scale that assesses the broader psychological and interpersonal outcomes associated with erectile dysfunction and its treatment. Time Concerns score is the average of responses on 8 PAIRS item scores. Time Concerns scores range from 1 (strongly disagree) to 4 (strongly agree). Higher scores are indicative of greater sexual self-confidence.	baseline, 8 weeks of each treatment
Change From Baseline to Endpoint in the Erectile Function Domain of the International Index of Erectile Function (IIEF)	Self-reported erectile function over the past 4 weeks. Scores range from 0 (low or no erectile function) to 5 (high erectile function) on 6 questions (1-5, 15 of the IIEF). Total Erectile Function Domain scores range from 0 to 30.	baseline, 8 weeks of each treatment
Change From Baseline to Endpoint in the Proportion of Days With at Least One Morning Erection		baseline, 8 weeks of each treatment
Change From Baseline to Endpoint in the Intercourse Satisfaction (IS) Domain of the IIEF	Self-reported intercourse satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction to 5 (high satisfaction), thus the 3 questions of the IIEF-IS domain range from 0 to 15.	baseline, 8 weeks of each treatment
Change From Baseline to Endpoint in the Overall Satisfaction (OS) Domain of the IIEF	Self-reported overall satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction to 5 (high satisfaction), thus the 2 questions of the IIEF-OS domain range from 0 to 10.	baseline, 8 weeks of each treatment
Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Score at Endpoint	EDITS is a questionnaire-based inventory capturing a participant's subjective evaluation of treatment for the participant's erection problems. All items on the 11-item Patient EDITS were scored from zero (no satisfaction or dissatisfaction) to four (high satisfaction). The EDITS Summary Score (transformed) is obtained by adding each individual score for all questions, dividing by the number of questions, and multiplying by 25, so that EDITS scores could range from a low of 0 (extremely low treatment satisfaction) to a high of 100 (extremely high treatment satisfaction).	8 weeks of each treatment
Number of Participants With at Least One Serious Adverse Event	Serious adverse events are listed in the Reported Adverse Event module.	baseline through 26 weeks (including two washout periods of 1 week each)
Change From Baseline to Endpoint in the Self-Esteem And Relationship (SEAR) Questionnaire Transformed Total Score	Measures improvement in self-esteem and relationship satisfaction. Questionnaire consists of two domains, Sexual Relationship (items 1-8) and Confidence (items 9-14). Overall score is transformed onto a 0 (least favorable) to 100 (most favorable) scale. Overall score was calculated from two domains and subscales scores.	baseline, 8 weeks of each treatment
Question 1 "I Felt as if I Did Not Have ED" Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint	Scores for Question 1 range from 0 (not at all) to 4 (extremely).	8 weeks of each treatment
Question 2 "I Felt in Control of my Sex Life" Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint	Scores for Question 2 range from 0 (not at all) to 4 (extremely).	8 weeks of each treatment
Question 3 "I Felt the Drug Was in Control of my Erections" Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint	Scores for Question 3 range from 0 (not at all) to 4 (extremely).	8 weeks of each treatment
Question 4 "I Felt Like a Whole Man" Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint	Scores for Question 4 range from 0 (not at all) to 4 (extremely).	8 weeks of each treatment

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: August 12, 2008
• First Submitted That Met QC Criteria: August 12, 2008
• First Posted (Estimate): August 14, 2008

Study Record Updates

• Last Update Posted (Estimate): November 18, 2010
• Last Update Submitted That Met QC Criteria: October 21, 2010
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Erectile Dysfunction; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate; Tadalafil
• Other Study ID Numbers: 12313; H6D-CR-S024 (Other Identifier: Eli Lilly and Company)