Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of Avanafil
NCT ID: NCT00903981
Last Updated: 2010-04-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
208 participants
INTERVENTIONAL
2009-03-31
2009-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Avanafil 100mg
Avanafil
2 tablets(Avanafil 100mg tablet + Placebo 200mg tablet), 30 minutes before sexual intercourse
Avanafil 200mg
Avanafil
2 Tablets(Avanafil 200mg tablet + Placebo 100mg tablet), 30 minutes before sexual intercourse
Placebo
Placebo
2 Tablets(Placebo 100mg tablet + Placebo 200mg tablet), 30 minutes before sexual intercourse
Interventions
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Avanafil
2 tablets(Avanafil 100mg tablet + Placebo 200mg tablet), 30 minutes before sexual intercourse
Avanafil
2 Tablets(Avanafil 200mg tablet + Placebo 100mg tablet), 30 minutes before sexual intercourse
Placebo
2 Tablets(Placebo 100mg tablet + Placebo 200mg tablet), 30 minutes before sexual intercourse
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
19 Years
70 Years
MALE
No
Sponsors
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JW Pharmaceutical
INDUSTRY
Responsible Party
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ChoongWae Pharma Corporation
Principal Investigators
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Jong Kwan Park, PhD
Role: PRINCIPAL_INVESTIGATOR
Chonbuk National University Hospital
Se Woong Kim, PhD
Role: PRINCIPAL_INVESTIGATOR
Catholic Seoul medical center
Jae Suk Hyun, PhD
Role: PRINCIPAL_INVESTIGATOR
Gyeongsang National University Hospital
Je Jong Kim, PhD
Role: PRINCIPAL_INVESTIGATOR
Korea University
Nam Cheol Park, PhD
Role: PRINCIPAL_INVESTIGATOR
Pusan National University Hospital
Sung Won Lee, PhD
Role: PRINCIPAL_INVESTIGATOR
Samsung Medical Center
Jae Seung Paick, PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Tae young Ahn, PhD
Role: PRINCIPAL_INVESTIGATOR
Asan Medical Center
Ki Hak Moon, PhD
Role: PRINCIPAL_INVESTIGATOR
Yeungnam University Hospital
Woo Sik Chung, PhD
Role: PRINCIPAL_INVESTIGATOR
Ewha womans university hospital
Kweon Sik Min, PhD
Role: PRINCIPAL_INVESTIGATOR
Inje university Pusan paick hospital
Jun Kyu Suh, PhD
Role: PRINCIPAL_INVESTIGATOR
Inha University Hospital
Kwang Sung Park, PhD
Role: PRINCIPAL_INVESTIGATOR
Chonnam National University Hospital
Dae Yul Yang, PhD
Role: PRINCIPAL_INVESTIGATOR
Kangdong Sacred Heart Hospital
Locations
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Chonbuk national university hospital
Jeonju, Cholabukdo, South Korea
Countries
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Other Identifiers
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CWP-AVA-301
Identifier Type: -
Identifier Source: org_study_id
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