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

Primary Purpose

Erectile Dysfunction

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

tadalafil once a day [T(OaD)]

sildenafil citrate as needed [S(PRN)]

tadalafil as needed [T(PRN)]

About this trial

This is an interventional treatment trial for Erectile Dysfunction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Arm Label

T(OaD)/S(PRN)/T(PRN)

T(OaD)/T(PRN)/S(PRN)

S(PRN)/T(OaD)/T(PRN)

S(PRN)/T(PRN)/T(OaD)

T(PRN)/T(OaD)/S(PRN)

T(PRN)/S(PRN)/T(OaD)

Arm Description

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)

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.

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.

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.

Change From Baseline to Endpoint in the Proportion of Days With at Least One Morning Erection

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.

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.

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).

Number of Participants With at Least One Serious Adverse Event

Serious adverse events are listed in the Reported Adverse Event module.

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.

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).

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).

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).

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).

Full Information

NCT ID

NCT00734604

First Posted

August 12, 2008

Last Updated

October 21, 2010

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT00734604

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2010

Overall Recruitment Status

Completed

Study Start Date

August 2008 (undefined)

Primary Completion Date

September 2009 (Actual)

Study Completion Date

September 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Erectile Dysfunction

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

378 (Actual)

8. Arms, Groups, and Interventions

Arm Title

T(OaD)/S(PRN)/T(PRN)

Arm Type

Experimental

Arm Description

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

Arm Title

T(OaD)/T(PRN)/S(PRN)

Arm Type

Experimental

Arm Description

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

Arm Title

S(PRN)/T(OaD)/T(PRN)

Arm Type

Experimental

Arm Description

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

Arm Title

S(PRN)/T(PRN)/T(OaD)

Arm Type

Experimental

Arm Description

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

Arm Title

T(PRN)/T(OaD)/S(PRN)

Arm Type

Experimental

Arm Description

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

Arm Title

T(PRN)/S(PRN)/T(OaD)

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

tadalafil once a day [T(OaD)]

Other Intervention Name(s)

Cialis, LY450190

Intervention Description

5 mg tablet taken once a day (OaD) by mouth for 8 weeks

Intervention Type

Drug

Intervention Name(s)

sildenafil citrate as needed [S(PRN)]

Intervention Description

100 mg tablet taken as needed (PRN) by mouth for 8 weeks

Intervention Type

Drug

Intervention Name(s)

tadalafil as needed [T(PRN)]

Other Intervention Name(s)

Cialis, LY450190

Intervention Description

20 mg tablet taken as needed (PRN) by mouth for 8 weeks

Primary Outcome Measure Information:

Title

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)

Description

Time Frame

baseline, 8 weeks of each treatment

Secondary Outcome Measure Information:

Title

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)

Description

Time Frame

baseline, 8 weeks of each treatment

Title

Change From Baseline to Endpoint in the Spontaneity Domain of PAIRS

Description

Time Frame

baseline, 8 weeks of each treatment

Title

Change From Baseline to Endpoint in the Time Concerns Domain of PAIRS

Description

Time Frame

baseline, 8 weeks of each treatment

Title

Change From Baseline to Endpoint in the Erectile Function Domain of the International Index of Erectile Function (IIEF)

Description

Time Frame

baseline, 8 weeks of each treatment

Title

Change From Baseline to Endpoint in the Proportion of Days With at Least One Morning Erection

Time Frame

baseline, 8 weeks of each treatment

Title

Change From Baseline to Endpoint in the Intercourse Satisfaction (IS) Domain of the IIEF

Description

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.

Time Frame

baseline, 8 weeks of each treatment

Title

Change From Baseline to Endpoint in the Overall Satisfaction (OS) Domain of the IIEF

Description

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.

Time Frame

baseline, 8 weeks of each treatment

Title

Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Score at Endpoint

Description

Time Frame

8 weeks of each treatment

Title

Number of Participants With at Least One Serious Adverse Event

Description

Serious adverse events are listed in the Reported Adverse Event module.

Time Frame

baseline through 26 weeks (including two washout periods of 1 week each)

Title

Change From Baseline to Endpoint in the Self-Esteem And Relationship (SEAR) Questionnaire Transformed Total Score

Description

Time Frame

baseline, 8 weeks of each treatment

Title

Question 1 "I Felt as if I Did Not Have ED" Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint

Description

Scores for Question 1 range from 0 (not at all) to 4 (extremely).

Time Frame

8 weeks of each treatment

Title

Question 2 "I Felt in Control of my Sex Life" Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint

Description

Scores for Question 2 range from 0 (not at all) to 4 (extremely).

Time Frame

8 weeks of each treatment

Title

Question 3 "I Felt the Drug Was in Control of my Erections" Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint

Description

Scores for Question 3 range from 0 (not at all) to 4 (extremely).

Time Frame

8 weeks of each treatment

Title

Question 4 "I Felt Like a Whole Man" Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint

Description

Scores for Question 4 range from 0 (not at all) to 4 (extremely).

Time Frame

8 weeks of each treatment

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

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.

City

Huntsville

State/Province

Alabama

ZIP/Postal Code

35801

Country

United States

Facility Name

City

Newport Beach

State/Province

California

ZIP/Postal Code

92660

Country

United States

Facility Name

City

Middlebury

State/Province

Connecticut

ZIP/Postal Code

06762

Country

United States

Facility Name

City

Plantation

State/Province

Florida

ZIP/Postal Code

33317

Country

United States

Facility Name

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37920

Country

United States

Facility Name

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

City

Federal Way

State/Province

Washington

ZIP/Postal Code

98003

Country

United States

Facility Name

City

Adelaide

State/Province

South Australia

ZIP/Postal Code

5000

Country

Australia

Facility Name

City

Malvern

State/Province

Victoria

ZIP/Postal Code

3144

Country

Australia

Facility Name

City

Nedlands

State/Province

Western Australia

ZIP/Postal Code

6009

Country

Australia

Facility Name

City

Goiânia

ZIP/Postal Code

74110-020

Country

Brazil

Facility Name

City

Rio Claro

ZIP/Postal Code

13500-020

Country

Brazil

Facility Name

City

Rio De Janeiro

ZIP/Postal Code

20725-090

Country

Brazil

Facility Name

City

Sao Jose Rio Preto

ZIP/Postal Code

15090-000

Country

Brazil

Facility Name

City

Sao Paulo

ZIP/Postal Code

04044-060

Country

Brazil

Facility Name

City

Augsburg

ZIP/Postal Code

86150

Country

Germany

Facility Name

City

Berlin

ZIP/Postal Code

13465

Country

Germany

Facility Name

City

Hamburg

ZIP/Postal Code

20354

Country

Germany

Facility Name

City

Milan

ZIP/Postal Code

20132

Country

Italy

Facility Name

City

Sassari

ZIP/Postal Code

07100

Country

Italy

Facility Name

City

Torino

ZIP/Postal Code

10126

Country

Italy

Facility Name

City

La Joya

ZIP/Postal Code

14000

Country

Mexico

Facility Name

City

Mexico City

ZIP/Postal Code

10700

Country

Mexico

Facility Name

City

Monterrey

ZIP/Postal Code

64040

Country

Mexico

Facility Name

City

San Juan

ZIP/Postal Code

00912

Country

Puerto Rico

Facility Name

City

Santurce

ZIP/Postal Code

00907

Country

Puerto Rico

Facility Name

City

Barcelona

ZIP/Postal Code

08025

Country

Spain

Facility Name

City

La Coruña

ZIP/Postal Code

15006

Country

Spain

Facility Name

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

City

Malaga

ZIP/Postal Code

29007

Country

Spain

Facility Name

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

Facility Name

City

Vigo

ZIP/Postal Code

36211

Country

Spain

Facility Name

City

Durham

State/Province

County Durham

ZIP/Postal Code

DH1 2QW

Country

United Kingdom

Facility Name

City

Plymouth

State/Province

Devonshire

ZIP/Postal Code

PL6 8BX

Country

United Kingdom

Facility Name

City

Lichfield

State/Province

Staffordshire

ZIP/Postal Code

WS14 9JL

Country

United Kingdom

Facility Name

City

Leeds

State/Province

West Yorkshire

ZIP/Postal Code

LS9 7TF

Country

United Kingdom

Facility Name

City

London

ZIP/Postal Code

NW8 9NH

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

22429760

Citation

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.

Results Reference

derived

Learn more about this trial

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

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