Erectile DysfunctionPhase 3NCT00734604

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

A Phase 3 study testing tadalafil once a day [T(OaD)], sildenafil citrate as needed [S(PRN)] and tadalafil as needed [T(PRN)] in people with Erectile Dysfunction, run by Eli Lilly and Company at 37 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Erectile Dysfunction
What is being tested?: tadalafil once a day [T(OaD)], sildenafil citrate as needed [S(PRN)] and tadalafil as needed [T(PRN)]
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 378 participants
Where: 37 sitesin 9 countries
Study dates: Aug 2008to Sep 2009
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 16Show fewer

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.

Trial locations and contacts

37 sites in 9 countries.

Country

City, postcode or hospital

37 sites in 9 countries

United States7 sites

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
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Huntsville, Alabama, 35801
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Knoxville, Tennessee, 37920
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Middlebury, Connecticut, 06762
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Newport Beach, California, 92660
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Plantation, Florida, 33317
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San Antonio, Texas, 78229

Other trials in United States

Spain6 sites

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A Coruña, 15006
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Barcelona, 08025
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Madrid, 28040
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Málaga, 29007
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Seville, 41013
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Vigo, 36211

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Brazil5 sites

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Goiânia, 74110-020
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Rio Claro, 13500-020
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Rio de Janeiro, 20725-090
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Sao Jose Rio Preto, 15090-000
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São Paulo, 04044-060

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United Kingdom5 sites

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Durham, County Durham, DH1 2QW
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Leeds, West Yorkshire, LS9 7TF
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Lichfield, Staffordshire, WS14 9JL
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London, NW8 9NH
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Plymouth, Devonshire, PL6 8BX

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Australia3 sites

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Adelaide, South Australia, 5000
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Malvern, Victoria, 3144
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Nedlands, Western Australia, 6009

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Germany3 sites

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Augsburg, 86150
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Berlin, 13465
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Hamburg, 20354

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Italy3 sites

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Milan, 20132
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Sassari, 07100
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Torino, 10126

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Mexico3 sites

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La Joya, 14000
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Mexico City, 10700
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Monterrey, 64040

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Puerto Rico2 sites

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San Juan, 00912
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Santurce, 00907

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About this study

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

Conditions: Erectile Dysfunction
Being tested: tadalafil once a day [T(OaD)], sildenafil citrate as needed [S(PRN)], tadalafil as needed [T(PRN)]
Medical subject headings: Erectile Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

tadalafil once a day [T(OaD)]Drug
Also called Cialis, LY450190
5 mg tablet taken once a day (OaD) by mouth for 8 weeks
sildenafil citrate as needed [S(PRN)]Drug
100 mg tablet taken as needed (PRN) by mouth for 8 weeks
tadalafil as needed [T(PRN)]Drug
Also called Cialis, LY450190
20 mg tablet taken as needed (PRN) by mouth for 8 weeks

Study groups in NCT00734604
Study group	Role	What they receive
T(OaD)/S(PRN)/T(PRN)	Experimental	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 Receives: Drug: tadalafil once a day [T(OaD)]; Drug: sildenafil citrate as needed [S(PRN)]; Drug: tadalafil as needed [T(PRN)]
T(OaD)/T(PRN)/S(PRN)	Experimental	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 Receives: Drug: tadalafil once a day [T(OaD)]; Drug: sildenafil citrate as needed [S(PRN)]; Drug: tadalafil as needed [T(PRN)]
S(PRN)/T(OaD)/T(PRN)	Experimental	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 Receives: Drug: tadalafil once a day [T(OaD)]; Drug: sildenafil citrate as needed [S(PRN)]; Drug: tadalafil as needed [T(PRN)]
S(PRN)/T(PRN)/T(OaD)	Experimental	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 Receives: Drug: tadalafil once a day [T(OaD)]; Drug: sildenafil citrate as needed [S(PRN)]; Drug: tadalafil as needed [T(PRN)]
T(PRN)/T(OaD)/S(PRN)	Experimental	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 Receives: Drug: tadalafil once a day [T(OaD)]; Drug: sildenafil citrate as needed [S(PRN)]; Drug: tadalafil as needed [T(PRN)]
T(PRN)/S(PRN)/T(OaD)	Experimental	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 Receives: Drug: tadalafil once a day [T(OaD)]; Drug: sildenafil citrate as needed [S(PRN)]; Drug: tadalafil as needed [T(PRN)]

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: baseline, 8 weeks of each treatment

Secondary outcomes (14)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline, 8 weeks of each treatment
Change From Baseline to Endpoint in the Proportion of Days With at Least One Morning Erection
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 8 weeks of each treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2008Sep 2009

First posted14 Aug 2008 (estimated)
Study startAug 2008
Primary completionSep 2009
Study completionSep 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 378 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00734604
Sponsor's protocol ID: 12313
Other IDs: H6D-CR-S024
Status last verified: Oct 2010
First submitted: 12 Aug 2008
Last updated: 18 Nov 2010
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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.
PubMed 22429760

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 18 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Comparison of Psychosocial Outcomes Following Tadalafil Once a Day or PDE5 Inhibitor As Needed in Men With Erectile Dysfunction.
ClinicalTrials.gov ID: NCT00734604
Acronym / sponsor ID: 12313
Conditions: Erectile Dysfunction
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 378 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Aug 2008
Primary completion: Sep 2009 (actual)
Study completion: Sep 2009 (actual)
First posted: 14 Aug 2008 (estimated)
Results: Posted 18 Nov 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
T(OaD)/S(PRN)/T(PRN)	Experimental	Drug: tadalafil once a day [T(OaD)], Drug: sildenafil citrate as needed [S(PRN)], Drug: tadalafil as needed [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
T(OaD)/T(PRN)/S(PRN)	Experimental	Drug: tadalafil once a day [T(OaD)], Drug: sildenafil citrate as needed [S(PRN)], Drug: tadalafil as needed [T(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
S(PRN)/T(OaD)/T(PRN)	Experimental	Drug: tadalafil once a day [T(OaD)], Drug: sildenafil citrate as needed [S(PRN)], Drug: tadalafil as needed [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
S(PRN)/T(PRN)/T(OaD)	Experimental	Drug: tadalafil once a day [T(OaD)], Drug: sildenafil citrate as needed [S(PRN)], Drug: tadalafil as needed [T(PRN)]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
T(PRN)/T(OaD)/S(PRN)	Experimental	Drug: tadalafil once a day [T(OaD)], Drug: sildenafil citrate as needed [S(PRN)], Drug: tadalafil as needed [T(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
T(PRN)/S(PRN)/T(OaD)	Experimental	Drug: tadalafil once a day [T(OaD)], Drug: sildenafil citrate as needed [S(PRN)], Drug: tadalafil as needed [T(PRN)]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

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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.

Key exclusion criteria (16 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
tadalafil once a day [T(OaD)]Also: Cialis, LY4501905 mg tablet taken once a day (OaD) by mouth for 8 weeks	Drug	S(PRN)/T(OaD)/T(PRN), S(PRN)/T(PRN)/T(OaD), T(OaD)/S(PRN)/T(PRN), T(OaD)/T(PRN)/S(PRN), T(PRN)/S(PRN)/T(OaD), T(PRN)/T(OaD)/S(PRN)
sildenafil citrate as needed [S(PRN)]100 mg tablet taken as needed (PRN) by mouth for 8 weeks	Drug	S(PRN)/T(OaD)/T(PRN), S(PRN)/T(PRN)/T(OaD), T(OaD)/S(PRN)/T(PRN), T(OaD)/T(PRN)/S(PRN), T(PRN)/S(PRN)/T(OaD), T(PRN)/T(OaD)/S(PRN)
tadalafil as needed [T(PRN)]Also: Cialis, LY45019020 mg tablet taken as needed (PRN) by mouth for 8 weeks	Drug	S(PRN)/T(OaD)/T(PRN), S(PRN)/T(PRN)/T(OaD), T(OaD)/S(PRN)/T(PRN), T(OaD)/T(PRN)/S(PRN), T(PRN)/S(PRN)/T(OaD), T(PRN)/T(OaD)/S(PRN)

Primary outcome

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)
Time frame: baseline, 8 weeks of each treatment
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.

14 secondary outcomes

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)
Time frame: baseline, 8 weeks of each treatment
Change From Baseline to Endpoint in the Spontaneity Domain of PAIRS
Time frame: baseline, 8 weeks of each treatment
Change From Baseline to Endpoint in the Time Concerns Domain of PAIRS
Time frame: baseline, 8 weeks of each treatment
Change From Baseline to Endpoint in the Erectile Function Domain of the International Index of Erectile Function (IIEF)
Time frame: baseline, 8 weeks of each treatment
Change From Baseline to Endpoint in the Proportion of Days With at Least One Morning Erection
Time frame: baseline, 8 weeks of each treatment
Change From Baseline to Endpoint in the Intercourse Satisfaction (IS) Domain of the IIEF
Time frame: baseline, 8 weeks of each treatment
Change From Baseline to Endpoint in the Overall Satisfaction (OS) Domain of the IIEF
Time frame: baseline, 8 weeks of each treatment
Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Score at Endpoint
Time frame: 8 weeks of each treatment
Number of Participants With at Least One Serious Adverse Event
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 8 weeks of each treatment

Results and safety

Results posted to the registry on 18 Nov 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
T(OaD)/S(PRN)/T(PRN)	62	59
T(OaD)/T(PRN)/S(PRN)	63	51
S(PRN)/T(OaD)/T(PRN)	63	57
S(PRN)/T(PRN)/T(OaD)	63	54
T(PRN)/T(OaD)/S(PRN)	63	55
T(PRN)/S(PRN)/T(OaD)	64	58

Primary outcome: 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)

Time frame: baseline, 8 weeks of each treatment. Mean (Standard Deviation). Unit: units on a scale

Measure	Tadalafil Once a Day [T(OaD)] n = 351	Sildenafil as Needed [S(PRN)] n = 347
Baseline	2.24 (0.62)	2.23 (0.63)
Change from Baseline	0.50 (0.78)	0.39 (0.67)

Tadalafil Once a Day [T(OaD)] vs Sildenafil as Needed [S(PRN)]: Mean Difference (Final Values): 0.12 (95% CI 0.04 to 0.19), p = 0.001, t-test

14 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tadalafil Once a Day [T(OaD)]	4 of 378 (1.1%)	66 of 378 (17.5%)	Not reported
Sildenafil Citrate as Needed [S(PRN)]	5 of 378 (1.3%)	73 of 378 (19.3%)	Not reported
Tadalafil as Needed [T(PRN)]	2 of 378 (0.5%)	70 of 378 (18.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2010.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22429760Rubio-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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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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) study director

Eli Lilly and Company

37 sites in 9 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in United States, Spain, Brazil, United Kingdom, Australia and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Nov 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) (time frame: baseline, 8 weeks of each treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00734604, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2010.