Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of Avanafil

Erectile Dysfunction Clinical Trial

— ALERT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00903981
• Other study ID #: CWP-AVA-301
• Status: Completed
• Phase: Phase 3
• First received: May 18, 2009
• Last updated: April 22, 2010
• Start date: March 2009
• Est. completion date: November 2009

Study information

• Verified date: February 2009
• Source: JW Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: November 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 19 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Korea, Republic of	Chonbuk national university hospital	Chonju	Cholabukdo

Sponsors (1)

Lead Sponsor	Collaborator
JW Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of EF domain score in the IIEF(The International Index of Erectile Function)		12 weeks	No
Secondary	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	No