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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00734604
Registration number
NCT00734604
Ethics application status
Date submitted
12/08/2008
Date registered
14/08/2008
Date last updated
18/11/2010
Titles & IDs
Public title
A Study for Patients With Erectile Dysfunction to Test Whether Tadalafil Taken Once a Day Can Better Improve Psychological Outcomes.
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Scientific title
A Comparison of Psychosocial Outcomes Following Tadalafil Once a Day or PDE5 Inhibitor As Needed in Men With Erectile Dysfunction.
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Secondary ID [1]
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H6D-CR-S024
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Secondary ID [2]
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12313
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Erectile Dysfunction
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Condition category
Condition code
Renal and Urogenital
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Other renal and urogenital disorders
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Mental Health
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Other mental health disorders
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Reproductive Health and Childbirth
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Other reproductive health and childbirth disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - tadalafil once a day [T(OaD)]
Treatment: Drugs - sildenafil citrate as needed [S(PRN)]
Treatment: Drugs - tadalafil as needed [T(PRN)]
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
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
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
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
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
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
Treatment: Drugs: tadalafil once a day [T(OaD)]
5 mg tablet taken once a day (OaD) by mouth for 8 weeks
Treatment: Drugs: sildenafil citrate as needed [S(PRN)]
100 mg tablet taken as needed (PRN) by mouth for 8 weeks
Treatment: Drugs: tadalafil as needed [T(PRN)]
20 mg tablet taken as needed (PRN) by mouth for 8 weeks
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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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)
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Assessment method [1]
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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.
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Timepoint [1]
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baseline, 8 weeks of each treatment
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Secondary outcome [1]
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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)
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Assessment method [1]
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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.
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Timepoint [1]
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baseline, 8 weeks of each treatment
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Secondary outcome [2]
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Change From Baseline to Endpoint in the Spontaneity Domain of PAIRS
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Assessment method [2]
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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.
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Timepoint [2]
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baseline, 8 weeks of each treatment
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Secondary outcome [3]
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Change From Baseline to Endpoint in the Time Concerns Domain of PAIRS
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Assessment method [3]
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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.
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Timepoint [3]
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baseline, 8 weeks of each treatment
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Secondary outcome [4]
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Change From Baseline to Endpoint in the Erectile Function Domain of the International Index of Erectile Function (IIEF)
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Assessment method [4]
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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.
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Timepoint [4]
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baseline, 8 weeks of each treatment
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Secondary outcome [5]
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Change From Baseline to Endpoint in the Proportion of Days With at Least One Morning Erection
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Assessment method [5]
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Timepoint [5]
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baseline, 8 weeks of each treatment
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Secondary outcome [6]
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Change From Baseline to Endpoint in the Intercourse Satisfaction (IS) Domain of the IIEF
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Assessment method [6]
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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.
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Timepoint [6]
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baseline, 8 weeks of each treatment
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Secondary outcome [7]
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Change From Baseline to Endpoint in the Overall Satisfaction (OS) Domain of the IIEF
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Assessment method [7]
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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.
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Timepoint [7]
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baseline, 8 weeks of each treatment
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Secondary outcome [8]
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Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Score at Endpoint
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Assessment method [8]
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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).
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Timepoint [8]
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8 weeks of each treatment
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Secondary outcome [9]
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Number of Participants With at Least One Serious Adverse Event
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Assessment method [9]
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Serious adverse events are listed in the Reported Adverse Event module.
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Timepoint [9]
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baseline through 26 weeks (including two washout periods of 1 week each)
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Secondary outcome [10]
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Change From Baseline to Endpoint in the Self-Esteem And Relationship (SEAR) Questionnaire Transformed Total Score
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Assessment method [10]
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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.
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Timepoint [10]
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baseline, 8 weeks of each treatment
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Secondary outcome [11]
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Question 1 "I Felt as if I Did Not Have ED" Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint
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Assessment method [11]
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Scores for Question 1 range from 0 (not at all) to 4 (extremely).
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Timepoint [11]
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8 weeks of each treatment
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Secondary outcome [12]
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Question 2 "I Felt in Control of my Sex Life" Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint
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Assessment method [12]
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Scores for Question 2 range from 0 (not at all) to 4 (extremely).
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Timepoint [12]
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8 weeks of each treatment
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Secondary outcome [13]
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Question 3 "I Felt the Drug Was in Control of my Erections" Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint
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Assessment method [13]
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Scores for Question 3 range from 0 (not at all) to 4 (extremely).
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Timepoint [13]
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8 weeks of each treatment
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Secondary outcome [14]
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Question 4 "I Felt Like a Whole Man" Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint
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Assessment method [14]
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Scores for Question 4 range from 0 (not at all) to 4 (extremely).
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Timepoint [14]
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8 weeks of each treatment
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/09/2009
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Sample size
Target
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Accrual to date
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Final
378
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Recruitment in Australia
Recruitment state(s)
SA,VIC,WA
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Recruitment hospital [1]
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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. - Adelaide
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Recruitment hospital [2]
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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. - Malvern
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Recruitment hospital [3]
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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. - Nedlands
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Recruitment postcode(s) [2]
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3144 - Malvern
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Recruitment postcode(s) [3]
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6009 - Nedlands
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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United States of America
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California
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United States of America
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Connecticut
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United States of America
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Florida
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Washington
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Brazil
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Goiânia
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Brazil
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Rio Claro
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Brazil
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Rio De Janeiro
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Brazil
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Sao Jose Rio Preto
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Brazil
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Sao Paulo
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Germany
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Augsburg
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Germany
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Berlin
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Germany
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Hamburg
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Italy
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Milan
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Italy
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Sassari
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Italy
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Torino
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Mexico
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La Joya
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Mexico
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Mexico City
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Mexico
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Monterrey
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Puerto Rico
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San Juan
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Puerto Rico
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Santurce
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Spain
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Barcelona
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Spain
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La Coruña
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Spain
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Madrid
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Spain
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Malaga
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Spain
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Sevilla
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Spain
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Vigo
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United Kingdom
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County Durham
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United Kingdom
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Devonshire
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United Kingdom
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Staffordshire
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United Kingdom
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West Yorkshire
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United Kingdom
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Eli Lilly and Company
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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).
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Trial website
https://clinicaltrials.gov/study/NCT00734604
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Trial related presentations / 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.
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Public notes
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Contacts
Principal investigator
Name
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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)
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Address
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Eli Lilly and Company
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00734604
Download to PDF