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

Study Overview
=================
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).

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

Intervention / Treatment
-----------------
* Drug: tadalafil once a day [T(OaD)]
* Drug: sildenafil citrate as needed [S(PRN)]
* Drug: tadalafil as needed [T(PRN)]


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

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 |