To Determine How Different Doses of Tadalafil Work on Getting and Keeping an Erection 26 or 36 Hours After Taking

Study Overview
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Brief Summary
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Study to see how effective different doses of tadalafil are for getting and keeping an erection when sex is attempted after a certain number of hours.

Official Title
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A Randomized, Double-Blind, Parallel, Placebo-Controlled Study in Men With Erectile Dysfunction to Evaluate the Efficacy and Safety of Tadalafil When Sexual Attempts Occur at Specific Time Points After Dosing

Conditions
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Impotence

Intervention / Treatment
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* Drug: tadalafil
* Drug: placebo
* Drug: tadalafil
* Drug: tadalafil
* Drug: tadalafil
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 3 months history of erectile dysfunction (ED) Anticipate a monogamous relationship with a female sexual partner Be able to make minimum required sexual intercourse attempts Abstain from using any other ED treatment Exclusion Criteria: History of other primary sexual disorder Treatment with nitrates Have a penile implant or clinically significant penile deformity History of certain heart problems Do not meet certain lab value reference ranges

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Placebo | Drug: placebo<br>* Placebo tablet taken by mouth, no more than once a day, anytime during the 2-4 week equilibration phase and then 24 hours prior to sexual intercourse for 4-6 weeks in the assessment phase<br>|
| Placebo Comparator: 2<br>Placebo | Drug: placebo<br>* Placebo tablet taken by mouth, no more than once a day, anytime during the 2-4 week equilibration phase and then 36 hours prior to sexual intercourse for 4-6 weeks in the assessment phase<br>|
| Active Comparator: 3<br>tadalafil | Drug: tadalafil<br>* 10 mg tablet taken orally, no more than once a day, at anytime during the 2-4 week equilibration phase and then 36 hours prior to sexual intercourse for 4-6 weeks in the assessment phase<br>* Other names: IC351;|
| Active Comparator: 4<br>tadalafil | Drug: tadalafil<br>* 10 mg tablet taken orally, no more than once a day, at anytime during the 2-4 week equilibration phase and then 24 hours prior to sexual intercourse for 4-6 weeks in the assessment phase<br>* Other names: IC351;|
| Active Comparator: 5<br>tadalafil | Drug: tadalafil<br>* 20 mg tablet taken orally, no more than once a day, at anytime during the 2-4 week equilibration phase and then 24 hours prior to sexual intercourse for 4-6 weeks in the assessment phase<br>* Other names: IC351;|
| Active Comparator: 6<br>tadalafil | Drug: tadalafil<br>* 20 mg tablet taken orally, no more than once a day, at anytime during the 2-4 week equilibration phase and then 36 hours prior to sexual intercourse for 4-6 weeks in the assessment phase<br>* Other names: IC351;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prove superiority to placebo by measuring question 3 of the SEP diary |  | 6-10 and 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare effectiveness when patient can freely choose time of sex versus when time of sex attempt is set by the score of question 3 in the SEP diary |  | 6-10 and 24 weeks |