Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of Avanafil

Phase 3

Completed

• Conditions: Erectile Dysfunction
• Interventions: Drug: Placebo; Drug: Avanafil

• Registration Number: NCT00903981
• Lead Sponsor: JW Pharmaceutical

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-02
• Study Start: 2009-03
• Study First Submitted: 2009-05-18
• Study First Submitted QC: 2009-05-18
• Study First Posted: 2009-05-19
• Primary Completion: 2009-10
• Study Completion: 2009-11
• Last Update Submitted: 2010-04-22
• Last Update Posted: 2010-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 208

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%

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Avanafil 100mg	Avanafil	-
Avanafil 200mg	Avanafil	-

Primary Outcome Measures

Name	Time	Method
Change of EF domain score in the IIEF(The International Index of Erectile Function)	12 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Chonbuk national university hospital; 🇰🇷 Chonju, Cholabukdo, Korea, Republic of