Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of Avanafil (ALERT)

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

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.

Study Overview

• Status: Completed
• Conditions: Erectile Dysfunction
• Intervention / Treatment: Drug: Avanafil; Drug: Avanafil; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 208
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Cholabukdo
    • Chonju, Cholabukdo, Korea, Republic of, 561-712
      • Chonbuk National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: JW Pharmaceutical
• Investigators: Principal Investigator: Jong Kwan Park, PhD, Chonbuk National University Hospital; Principal Investigator: Se Woong Kim, PhD, Catholic Seoul medical center; Principal Investigator: Jae Suk Hyun, PhD, Gyeongsang National University Hospital; Principal Investigator: Je Jong Kim, PhD, Korea University; Principal Investigator: Nam Cheol Park, PhD, Pusan National University Hospital; Principal Investigator: Sung Won Lee, PhD, Samsung Medical Center; Principal Investigator: Jae Seung Paick, PhD, Seoul National University Hospital; Principal Investigator: Tae young Ahn, PhD, Asan Medical Center; Principal Investigator: Ki Hak Moon, PhD, Yeungnam University Hospital; Principal Investigator: Woo Sik Chung, PhD, Ewha Womans University Hospital; Principal Investigator: Kweon Sik Min, PhD, Inje university Pusan paick hospital; Principal Investigator: Jun Kyu Suh, PhD, Inha University Hospital; Principal Investigator: Kwang Sung Park, PhD, Chonnam National University Hospital; Principal Investigator: Dae Yul Yang, PhD, Kangdong Sacred Heart Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): November 1, 2009

Study Registration Dates

• First Submitted: May 18, 2009
• First Submitted That Met QC Criteria: May 18, 2009
• First Posted (Estimate): May 19, 2009

Study Record Updates

• Last Update Posted (Estimate): April 23, 2010
• Last Update Submitted That Met QC Criteria: April 22, 2010
• Last Verified: February 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Erectile Dysfunction
• Other Study ID Numbers: CWP-AVA-301