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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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.
Scientific title
A Comparison of Psychosocial Outcomes Following Tadalafil Once a Day or PDE5 Inhibitor As Needed in Men With Erectile Dysfunction.
Secondary ID [1] 0 0
H6D-CR-S024
Secondary ID [2] 0 0
12313
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Erectile Dysfunction 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Mental Health 0 0 0 0
Other mental health disorders
Reproductive Health and Childbirth 0 0 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
baseline, 8 weeks of each treatment
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
baseline, 8 weeks of each treatment
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
baseline, 8 weeks of each treatment
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
baseline, 8 weeks of each treatment
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
baseline, 8 weeks of each treatment
Secondary outcome [5] 0 0
Change From Baseline to Endpoint in the Proportion of Days With at Least One Morning Erection
Timepoint [5] 0 0
baseline, 8 weeks of each treatment
Secondary outcome [6] 0 0
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.
Timepoint [6] 0 0
baseline, 8 weeks of each treatment
Secondary outcome [7] 0 0
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.
Timepoint [7] 0 0
baseline, 8 weeks of each treatment
Secondary outcome [8] 0 0
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).
Timepoint [8] 0 0
8 weeks of each treatment
Secondary outcome [9] 0 0
Number of Participants With at Least One Serious Adverse Event - Serious adverse events are listed in the Reported Adverse Event module.
Timepoint [9] 0 0
baseline through 26 weeks (including two washout periods of 1 week each)
Secondary outcome [10] 0 0
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.
Timepoint [10] 0 0
baseline, 8 weeks of each treatment
Secondary outcome [11] 0 0
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).
Timepoint [11] 0 0
8 weeks of each treatment
Secondary outcome [12] 0 0
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).
Timepoint [12] 0 0
8 weeks of each treatment
Secondary outcome [13] 0 0
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).
Timepoint [13] 0 0
8 weeks of each treatment
Secondary outcome [14] 0 0
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).
Timepoint [14] 0 0
8 weeks of each treatment

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.
Minimum age
18 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC,WA
Recruitment hospital [1] 0 0
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
Recruitment hospital [2] 0 0
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
Recruitment hospital [3] 0 0
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
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3144 - Malvern
Recruitment postcode(s) [3] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Tennessee
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
United States of America
State/province [7] 0 0
Washington
Country [8] 0 0
Brazil
State/province [8] 0 0
Goiânia
Country [9] 0 0
Brazil
State/province [9] 0 0
Rio Claro
Country [10] 0 0
Brazil
State/province [10] 0 0
Rio De Janeiro
Country [11] 0 0
Brazil
State/province [11] 0 0
Sao Jose Rio Preto
Country [12] 0 0
Brazil
State/province [12] 0 0
Sao Paulo
Country [13] 0 0
Germany
State/province [13] 0 0
Augsburg
Country [14] 0 0
Germany
State/province [14] 0 0
Berlin
Country [15] 0 0
Germany
State/province [15] 0 0
Hamburg
Country [16] 0 0
Italy
State/province [16] 0 0
Milan
Country [17] 0 0
Italy
State/province [17] 0 0
Sassari
Country [18] 0 0
Italy
State/province [18] 0 0
Torino
Country [19] 0 0
Mexico
State/province [19] 0 0
La Joya
Country [20] 0 0
Mexico
State/province [20] 0 0
Mexico City
Country [21] 0 0
Mexico
State/province [21] 0 0
Monterrey
Country [22] 0 0
Puerto Rico
State/province [22] 0 0
San Juan
Country [23] 0 0
Puerto Rico
State/province [23] 0 0
Santurce
Country [24] 0 0
Spain
State/province [24] 0 0
Barcelona
Country [25] 0 0
Spain
State/province [25] 0 0
La Coruña
Country [26] 0 0
Spain
State/province [26] 0 0
Madrid
Country [27] 0 0
Spain
State/province [27] 0 0
Malaga
Country [28] 0 0
Spain
State/province [28] 0 0
Sevilla
Country [29] 0 0
Spain
State/province [29] 0 0
Vigo
Country [30] 0 0
United Kingdom
State/province [30] 0 0
County Durham
Country [31] 0 0
United Kingdom
State/province [31] 0 0
Devonshire
Country [32] 0 0
United Kingdom
State/province [32] 0 0
Staffordshire
Country [33] 0 0
United Kingdom
State/province [33] 0 0
West Yorkshire
Country [34] 0 0
United Kingdom
State/province [34] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

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).
Trial website
https://clinicaltrials.gov/show/NCT00734604
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications