Tadalafil Taken Daily Compared to Placebo on Improvement of Getting and Maintaining an Erection and Sexual Quality of Life

Study Overview
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Brief Summary
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To determine if tadalafil 5 mg daily compared to placebo when given for 12 weeks improves getting and maintaining an erection in men with erectile dysfunction and if there are improvements in the sexual quality of life of the man and his female study partner

Official Title
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Tadalafil 5 mg Once a Day Compared to Placebo in Improving Erectile Dysfunction and Sexual Quality of Life

Conditions
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Impotence

Intervention / Treatment
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* Drug: tadalafil
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male History of erectile dysfunction (ED) for at least 3 months duration Anticipate having the same female partner willing to participate throughout the study At least 18 years of age at Visit 1 and agree to make at least 4 sexual attempts during the early phase of the study Adequate partner sexual function as determined by a Female Sexual Function Index Willing to record responses to efficacy questionnaires, sexual quality of life questionnaires and other instruments used in the study Exclusion Criteria: May not participate in the study if you have taken tadalafil previously. History of cardiac conditions including angina requiring treatment with nitrates, heart disease of coronary conditions including myocardial infarction, bypass surgery, angioplasty or stent placement for specified time before starting the study. Have sexual partner not willing to complete the scales. Use of nitrates.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Placebo | Drug: Placebo<br>* placebo tablet taken by mouth once a day for 12 weeks<br>|
| Active Comparator: 2<br>5 mg tadalafil | Drug: tadalafil<br>* 5 mg tadalafil tablet taken by mouth once a day for 12 weeks<br>* Other names: IC351;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF)- Erectile Function Domain Score (Sum of IIEF Questions 1-5 and 15) | Measures erectile function over the past 4 weeks on Questions 1-5 and 15 (6 questions) of the International Index of Erecile Function (IIEF) questionnaire. Scores range from 0 (low/no erectile function) to 5 (high erectile function), thus the 6 questions of the IIEF-EF domain range from 0 to 30. | Baseline and 12 weeks | 
| Improvement in the Sexual Quality of Life in the Subject and His Study Partner as Measured by the Sexual Quality of Life (SQoL) Domain of the Sexual Life Quality Questionnaire (SLQQ) | The original item scores (-4 to 4 range) were converted to 0 to 8 scale score by adding 4 to each recorded responses. Each transformed score was multiplied by 12.5 for a total range of 0 to 100. Higher scores are indicative of a higher sexual quality of life. | Baseline and 12 weeks | 
| Change From Baseline to Endpoint in the Percent of Yes Responses to Sexual Encounter Profile (SEP) Diary Questions 2 (SEP2) and 3 (SEP3). | The baseline and endpoint score for each SEP question 2 (Insert penis into vagina) and 3 (Successful intercourse) are the subject's percentage of yes responses to those questions during the run-in period and postbaseline period, respectively. | Baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to Week 12 Endpoint in the International Index of Erectile Function - Intercourse Satisfaction Domain - Subject Response | 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 and 12 weeks | 
| Change From Baseline to 12 Week Endpoint in Overall Satisfaction Domain of the International Index of Erectile Function (IIEF-OS) - Subject Response | 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 and 12 weeks | 
| Sexual Life Quality Questionnaire (SLQQ) Treatment Satisfaction Domain | The 6 SLQQ-treatment satisfaction questions were answered by subject and partner at Visit 4/Final Visit. Original item scores (1 to 6 range) were converted to 0 to 5 scale by subtracting 1 to each recorded responses. Each transformed score was multiplied by 20. Total range of scores: 0 (low satisfaction) to 100 (high satisfaction). | 12 weeks | 
| Change From Baseline to 12 Week Endpoint in Percent of Yes Responses to Sexual Encounter Profile (SEP) Questions 4 and 5 - Subject Response | The baseline and endpoint score for each SEP question 4 (Satisfied with hardness) and 5 (Satisfied overall) are the subject's percentage of yes responses to those questions during the run-in period and postbaseline period, respectively. | Baseline and 12 weeks | 
| Change From Baseline to 12 Week Endpoint in Percent of Yes Responses to Partner-Sexual Encounter Profile (SEP) Question 3 - Partner Response | The baseline and endpoint score for partner SEP question 3 (Satisfied overall) are the partner's percentage of yes responses to the question during the run-in period and postbaseline period, respectively. | Baseline and 12 weeks | 
| Change From Baseline to 12 Week Endpoint in the Satisfaction Domain of the Female Sexual Function Index (FSFI) - Partner Response | The FSFI Satisfaction Domain (items 14-16) measures satisfaction with emotional closeness, sexual relationship, and overall sexual life. Each question is scored on a 0/1 to 5 scale and domain score is calculated by multiplying the total points by 0.4, for a total score range of 0.8 to 6, with higher scores indicating greater satisfaction. | Baseline and 12 weeks | 
| Percent of Subjects With Yes Responses to Global Assessment Questionnaire (GAQ) - Subject Response | Percent of subjects with Yes responses to Question 1 (Improvement in Erections) and Question 2 (Improvement in the Ability to Engage in Sexual Activity) | 12 weeks | 
| Percent of Partners With Yes Responses to Global Assessment Questionnaire (GAQ) - Partner Response | Percent of Partners with Yes responses to Question 1 (Improvement in Erections) and Question 2 (Improvement in the Ability to Engage in Sexual Activity) | 12 weeks | 
| Change From Baseline to 12 Week Endpoint in Percent of Yes Responses to Partner-Sexual Encounter Profile (SEP) Questions 1 and 2 - Partner Response | The baseline and endpoint score for each SEP question 1 (Achieve some erection) and 2 (Insert penis into vagina) are the partner's percentage of yes responses to those questions during the run-in period and postbaseline period, respectively. | Baseline and 12 weeks | 
| Change From Baseline to 12 Week Endpoint in the Self-Esteem and Relationship (SEAR) Questionnaire | 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 and 12 weeks | 
| Change From Baseline to 12 Week Endpoint in the Self-Esteem and Relationship (SEAR) Questionnaire - Confidence Domain Subscales | Measures improvement in confidence (items 9-14). Confidence domain consists of two subscales (Self-Esteem, items 9-12; Overall Relationship, items 13 and 14). Each domain score, subscale score, and overall score are transformed onto a 0 (least favorable) to 100 (most favorable) scale. | Baseline and 12 weeks |