A Study in Erectile Dysfunction

Study Overview
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Brief Summary
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The purpose of this study is to determine the day of onset of efficacy of tadalafil dosed once-a-day.

Official Title
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Tadalafil 2.5 mg and 5 mg Once a Day Compared to Placebo in Day of Onset of Efficacy

Conditions
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Erectile Dysfunction

Intervention / Treatment
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* Drug: Placebo
* Drug: Tadalafil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and at least 18 years old, with at least a 3-month history of erectile dysfunction (ED). Anticipate having same adult female sexual partner during the study. Agree to make at least 4 sexual intercourse attempts with the female partner during the 4-week run-in phase without medication. Agree to make at least 1 sexual intercourse attempt per day with the female partner during days 1-4 following randomization (with a minimum of three attempts required during that period). Also agree to make at least 3 intercourse attempts during days 5-14 following randomization. Agree not to use any other ED treatment during the study and for 24 hours after the final study visit. Partner Inclusion Criteria: Female and at least 18 years old. Agree to make at least 4 sexual intercourse attempts with the male sexual study partner during the 4-week run-in phase without medication. Agree to make at least 1 sexual intercourse attempt per day with the male partner during days 1-4 following randomization Agree to make at least 3 intercourse attempts during days 5-14 following randomization. Exclusion Criteria: Previous or current treatment with tadalafil or any phosphodiesterase type 5 (PDE5) inhibitor on a daily basis for once daily use. ED caused by other primary sexual disorders, or untreated or inadequately treated endocrine disease. History of radical prostatectomy, other pelvic surgery or penile implant. Clinically significant penile deformity in the opinion of the investigator. Clinically significant renal insufficiency, or hepatobiliary disease as determined by the investigator. Glycosylated hemoglobin of >11%. Present with chronic stable angina treated with long-acting nitrates, or with chronic stable angina requiring short-acting nitrates in the last 90 days, or with angina occurring during sexual intercourse in the last 6 months. Have any significant cardiac conditions as described in the protocol exclusion criteria. Have a history of significant central nervous system injuries within the last 6 months. Have a history of Human Immunodeficiency Virus infection. Have any condition that would interfere with the subject's ability to provide informed consent or comply with study instructions, would place subject at increased risk, or might confound the interpretation of the study results. Currently receive treatment with nitrates, cancer chemotherapy, or antiandrogens (except finasteride taken as Propecia or Proscar, or Avodart [dutasteride]). History of drug, alcohol, or substance abuse within the past 6 months, as assessed by the investigator. Previously completed or withdrawn from any other study investigating tadalafil for once daily use. Received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry. Prior ineffective treatment with any PDE5 inhibitor in the opinion of the investigator.

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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Accepts Healthy Volunteers

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tadalafil 2.5 mg<br>No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days. | Drug: Tadalafil<br>* Orally once daily<br>* Other names: LY450190;|
| Experimental: Tadalafil 5 mg<br>No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days. | Drug: Tadalafil<br>* Orally once daily<br>* Other names: LY450190;|
| Placebo Comparator: Placebo<br>No drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days. | Drug: Placebo<br>* One tablet orally daily<br>Drug: Tadalafil<br>* Orally once daily<br>* Other names: LY450190;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Earliest Onset Day Measured by Cumulative Percentage of Participants With Yes Response to Sexual Encounter Profile Diary Question 3 | Cumulative percentage of participants achieving successful intercourse, as measured by yes responses to Sexual Encounter Profile diary question 3 (SEP3). SEP3 asks if the participant's erection lasted long enough to have successful intercourse. | 4 days during double-blind period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sexual Encounter Profile Diary Question Number 1, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses | Assessed was the mean change from baseline in the percentage of yes responses to the Sexual Encounter Profile Diary question number 1: Were you able to achieve at least some erection (some enlargement of the penis)? Data are presented as the mean percentage of participants who answered yes. | Baseline and 14 days double-blind period | 
| Sexual Encounter Profile Diary Question Number 2, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses | Assessed was the mean change from baseline in the percentage of yes responses to the Sexual Encounter Profile Diary question number 2: Were you able insert your penis into your partner's vagina? Data are presented as the mean percentage of participants who answered yes. | Baseline and 14 days double-blind period | 
| Sexual Encounter Profile Diary Question Number 3, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses | Assessed was the mean change from baseline in the percentage of yes responses to the Sexual Encounter Profile Diary question number 3: Did your erection last long enough for you to have successful intercourse? Data are presented as the mean percentage of participants who answered yes. | Baseline and 14 days double-blind period | 
| Sexual Encounter Profile Diary Question Number 4, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses | Assessed was the mean change from baseline in the percentage of yes responses to the Sexual Encounter Profile Diary question number 4: Were you satisfied with the hardness of your erection? Data are presented as the mean percentage of participants who answered yes. | Baseline and 14 days double-blind period | 
| Sexual Encounter Profile Diary Question Number 5, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses | Assessed was the mean change from baseline in the percentage of yes responses to the Sexual Encounter Profile Diary question number 5: Were you satisfied overall with this sexual experience? Data are presented as the mean percentage of participants who answered yes. | Baseline and 14 days double-blind period | 
| Sexual Encounter Profile Diary Question 3, the Overall Distribution of Time to Onset by Yes Responses | Assessed was the median time to onset of efficacy (day when 50% of participants have had at least 1 successful intercourse attempt) within the first 4 days of therapy based on a yes response to the sexual encounter profile diary question 3: Did your erection last long enough for you to have successful intercourse? Data are based on participants who responded yes. For the placebo group, onset of efficacy was not reached within the first 4 days of therapy, therefore, the analysis timeframe was expanded for this group to determine the median time to onset of efficacy. | 4 days double-blind period | 
| Sexual Encounter Profile Diary Question 3, Daily Cumulative Percentage of Successful Intercourse Attempts | Assessed was the cumulative precentage of successful intercourse attempts (successful attempts relative to the total number of intercourse attempts) over the 14-day double-blind treatment period. A successful attempt was defined by a yes response to the sexual encounter profile diary question #3: Did your erection last long enough for you to have successful intercourse? Data are presented as the proportion of intercourse attempts for which participants answered yes relative to the total number of intercourse attempts. Total number of attempts = TNA. | 14 days during double-blind period | 
| Sexual Encounter Profile Diary Question 3, Percentages of Yes Responses During the Double-blind and Open-label Periods for Participants Who Were Assigned to Placebo in the Double-blind Treatment Period | Assessed were percentages of successful intercourse attempts relative to the total number of intercourse attempts over the 14-day open-label treatment period compared with the 14-day double-blind treatment period by dose group during the double-blind treatment period. A successful attempt was defined by a yes response to the sexual encounter profile diary question #3: Did your erection last long enough for you to have successful intercourse? | 14 days double-blind and 14 days open-label | 
| Sexual Encounter Profile Diary Question 3, Percentages of Yes Responses in the Double-blind Period and the Open-label Period for Participants Who Were Assigned to Tadalafil 2.5 mg in the Double-blind Treatment Period | Assessed were percentages of successful intercourse attempts relative to the total number of intercourse attempts over the 14-day open-label treatment period compared with the 14-day double-blind treatment period by dose group during the double-blind treatment period. A successful attempt was defined by a yes response to the sexual encounter profile diary question #3: Did your erection last long enough for you to have successful intercourse? | 14-day double-blind and 14-day open-label | 
| Sexual Encounter Profile Diary Question 3, Percentages of Yes Responses in the Double-blind Period and the Open-label Period for Participants Who Were Assigned to Tadalafil 5 mg in the Double-blind Treatment Period | Assessed were percentages of successful intercourse attempts relative to the total number of intercourse attempts over the 14-day open-label treatment period compared with the 14-day double-blind treatment period by dose group during the double-blind treatment period. A successful attempt was defined by a yes response to the sexual encounter profile diary question #3: Did your erection last long enough for you to have successful intercourse? | 14-day double-blind and 14-day open-label | 
| Sexual Encounter Profile Diary Question 3, Percentages of Yes Responses During the Double-blind Period and the Open-label Period for Participants Who Didn't Respond to Tadalafil 2.5 mg During Double-blind Period | Assessed were percentages of successful intercourse attempts relative to the total number of intercourse attempts in both treatment periods. A successful attempt was defined by a yes response to the sexual encounter profile diary question #3: Did your erection last long enough for you to have successful intercourse? | 14 days double-blind and 14 days open-label | 

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