Effect of Tadalafil Once a Day in Men With Erectile Dysfunction

Study Overview
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Brief Summary
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The primary aim of this study is to assess the efficacy and safety of tadalafil 5 mg administered once a day in patients with erectile dysfunction (ED) who are naïve to PDE5 (phosphodiesterase type 5) inhibitors. Patients may be dose reduced to 2.5mg based on tolerability.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Assess the Efficacy and Safety of Tadalafil (LY450190) Once a Day in Subjects With Erectile Dysfunction Who Are Naïve to PDE5 Inhibitors

Conditions
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Erectile Dysfunction

Intervention / Treatment
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* Drug: tadalafil
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: You are male and aged at least 18 years. Have a history of erectile dysfunction (ED)(defined as the consistent inability to achieve and/or maintain an erection sufficient to permit satisfactory sexual intercourse) of at least 3 months duration. Agree not to use any other treatment for ED, including herbal and over-the-counter (OTC) medications, during the study You agree to make at least four sexual intercourse attempts with the female sexual study partner during the 4-week run-in period without medication Your entry laboratory test results and medical tests meet study requirements You agree to use the study drug only as instructed by your study doctor and staff and to return any unused study drug and containers at the end of the study or as otherwise instructed by the study doctor. If currently using cholesterol lowering medications (for example: statins) or medications to lower blood pressure (example: angiotensin-converting enzyme (ACE) inhibitors or calcium channel blocker medications), you need to be on a stable dose and you and your study doctor do not expect any dose change during the study. Exclusion Criteria: You have received previous or current treatment with tadalafil or any other PDE5 inhibitor. Currently receives treatment with doxazosin, nitrates, cancer chemotherapy, or anti-androgens (except finasteride e.g. Propecia™ or Proscar®, or dutasteride e.g. Avodart®). You have had significant heart disease as determined by your doctor in charge of this study or a member of the doctor's staff. Have a history of significant central nervous system injuries (including stroke or spinal cord injury) within the last 6 months. Have a history of loss of vision in one eye because of nonarteritic anterior ischemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure.

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 |
| --- | --- |
| Experimental: Tadalafil<br> | Drug: tadalafil<br>* 5 milligrams (mg) administered orally once a day for 12 weeks<br>* Other names: LY450190;|
| Placebo Comparator: Placebo<br> | Drug: placebo<br>* tablet administered orally once a day for 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) at Week 12 | 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, Week 12 | 
| Change From Baseline in Question 2 of the Patient Sexual Encounter Profile (SEP) Diary at Week 12 in Percentage of Yes Responses | Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 2. Were you able to insert your penis into your partner's vagina? Data are presented as the mean percentage of yes responses per participant. | Baseline, Week 12 | 
| Sexual Encounter Profile (SEP) Diary, Question 3 Change From Baseline to Week 12 in Percentage of Yes Responses | Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 3. Did your erection last long enough for you to have successful intercourse? Data are presented as the mean percentage of yes responses per participant. | Baseline, 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Number of Erectile Events Per Night | NPT was measured using electrobioimpedance volumetric assessment (NEVA). The NEVA device measures a man's erections during the night. The man wears the device for three nights prior to visit 2 (baseline), visit 5 (end of randomised treatment) and visit 6 (end of follow-up). Data are entered for the 2 nights prior to the visit. During the night the man may have multiple erections. The number of erections is recorded. | Baseline, Week 12 | 
| Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Duration of Erectile Events Per Night | NPT was measured using electrobioimpedance volumetric assessment (NEVA). The NEVA device measures a man's erections during the night. The duration of erections are measured and recorded. Data presented are the duration of erectile events at baseline and the change from baseline to Week 12. | Baseline, Week 12 | 
| Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Percentage Volumetric Change | NPT was measured using electrobioimpedance volumetric assessment (NEVA). The NEVA device measures a man's erections during the night. The percent of volume change of the penis during erections is measured and recorded for each erection. Data presented are mean percentage of volumetric change from baseline to Week 12. | Baseline, Week 12 | 
| Change From Baseline to 12 Week Endpoint in the Frequency of Spontaneous Morning Erections Captured by Patient Diary | The morning erection diary allows the participant to record whether he experienced an erection on waking. The participant is to complete the morning erection diary every morning during the run-in, treatment and follow-up periods. The percentage of mornings the participant reported an erection is analysed. | Baseline, 12 weeks | 
| The Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire at 12 Week Endpoint | The subject questionnaire consists of 11 questions. Each question is rated on a scale of 0 (extremely low treatment satisfaction) to 4 (extremely high treatment satisfaction). The EDITS summary score will be obtained by adding each individual result for all questions, dividing by the number of questions answered (mean satisfaction score), and multiplying by 25, thus obtaining a score that ranges from 0 (extremely low treatment satisfaction) to 100 (extremely high satisfaction). | Week 12 | 
| Change From Baseline to 12 Week Endpoint in Total and Subdomain Scores of the Self-Esteem and Relationship (SEAR) Questionnaire | SEAR measures improvement in self-esteem and relationship satisfaction. Questionnaire consists of two domains, Sexual Relationship (items 1-8) and Confidence (items 9-14). All questions except negatively worded questions 8 and 11 are scored from 1=almost never/never to 5=almost always/always. Questions 8 and 11 were reverse scored, thus a higher score signifies a more favorable response for all 14 items. Overall score is transformed into a 0 (least favorable) to 100 (most favorable) scale. | Baseline, Week 12 | 
| Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Orgasmic Functions (OF) | 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-OF domain range from 0 to 10. | Baseline, Week 12 | 
| Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Sexual Desire (SD) | 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-SD domain range from 0 to 10. | Baseline, 12 weeks | 
| Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Intercourse Satisfaction (IS) | 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, Week 12 | 
| Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Overall Satisfaction (OS) | 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, 12 weeks | 
| Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 1 Percentage of Yes Responses | Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 1. Were you able to achieve at least some erection (some enlargement of the penis)?  Data are presented as the mean percentage of yes responses per participant. | Baseline, 12 weeks | 
| Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 4 Percentage of Yes Responses | Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 4. Were you satisfied with the hardness of your erection? Data are presented as the mean percentage of yes responses per participant. | Baseline, 12 weeks | 
| Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 5 Percentage of Yes Responses | Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 5. Were you satisfied overall with this sexual experience? Data are presented as the mean percentage of yes responses per participant. | Baseline, 12 weeks | 
| Global Assessment Question (GAQ) Question 1 at 12 Week Endpoint | GAQ Question 1: Choose the one number which best describes how you perceive your ability to achieve and maintain your erections now, compared to how it was before you began taking medication in this study. Responses range from 1=very much better to 7=very much worse. | Week 12 | 
| Global Assessment Question (GAQ) Question 2 at 12 Week Endpoint | GAQ Question 2: Choose the one number which best describes how you perceive your sexual life is now, compared to how it was before you began taking medication in this study. Responses range from 1=very much better to 7=very much worse. | Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Erectile Dysfunction