Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of Avanafil

Study Overview
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Brief Summary
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The purpose of this study is to confirm the efficacy and the safety of Avanafil 100mg, 200mg or placebo administered orally for 12 weeks in patients with erectile dysfunction. The efficacy is evaluated by IIEF, SEP Q2 and Q3 and GEAQ and the safety is evaluated by laboratory tests, vital signs, physical examination and adverse events.

Official Title
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A Randomized, Placebo Controlled, Double Blind, Multicenter Therapeutic Confirmatory Clinical Study for the Evaluation of the Efficacy and Safety of Avanafil in the Patients With Erectile Dysfunction

Conditions
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Erectile Dysfunction

Intervention / Treatment
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* Drug: Avanafil
* Drug: Avanafil
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male subjects aged 19 to 70 with history of erectile dysfunction for at least 6 months subjects have stable monogamous relationships their partners are free from pregnancy and lactation and well prevent conception subjects consented to participate in the clinical study in writing subjects attempted sexual intercourse at least 4 times in separate days during 4 weeks' free run-in period, and failure rate is over 50% Exclusion Criteria: history of spinal cord injury or radical prostatectomy subjects whose penises are anatomically deformed erectile dysfunction due to neurogenic or endocrine cause subjects who have uncontrolled major psychiatric disorder and do not accept therapies or have significant neurological abnormalities history of cancer chemotherapy within 1 year subjects who are addicted to alcohol or have continuously misused dependent drugs subjects who have hepatic dysfunction(GOP,GPT ≥ 3xUNL) or renal dysfunctions(serum creatinine > 2.0) subjects who have uncontrollable diabetes(FPG>180) subjects sho have proliferative diabetic retinopathy history of stroke, transient ischemic attacks, myocardial infarction, heart failure that needs to be medically treated, unstable angina or fatal arrhythmia or coronary artery bypass graft within 6 months serious hypotension or uncontrollable severe hypertension hematological disorders that is likely to be developed into priapism such as sickle cell disease, multiple myeloma, leukemia subjects who have retinitis pigmentosa subjects who suffered from serious GI bleeding disorder within 1 year subjects who took other PDE5 inhibitors or ED therapies within 2 weeks subjects who use non-concomitant medications(Nitrate/NO donors, Androgens, anti-androgen, trazodone, Anticoagulant,over-the-counter drugs known to inhibit the activity of CYP3A4) history of hypersensitivity to the PDE5 inhibitors or not responded to them subjects who have hypoactive sexual desire subjects who have no intention of having sexual intercourses 4 times in separate days during 4 weeks' free run-in period subjects who took other investigational products within 30 days before this clinical study subjects who are judged to be unsuitable to the clinical study by other reasons

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 70 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Avanafil 100mg<br> | Drug: Avanafil<br>* 2 tablets(Avanafil 100mg tablet + Placebo 200mg tablet), 30 minutes before sexual intercourse<br>|
| Experimental: Avanafil 200mg<br> | Drug: Avanafil<br>* 2 Tablets(Avanafil 200mg tablet + Placebo 100mg tablet), 30 minutes before sexual intercourse<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 2 Tablets(Placebo 100mg tablet + Placebo 200mg tablet), 30 minutes before sexual intercourse<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of EF domain score in the IIEF(The International Index of Erectile Function) |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of successful rate in SEPQ2,Q3,Q4,Q5 Change of score in other domains of IIEF Change of IIEF Q3 and Q4 score GEAQ The rate of normal erectile function |  | 12 weeks |