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

JW Pharmaceutical

Status and phase

Completed

Phase 3

Conditions

Erectile Dysfunction

Treatments

Drug: Placebo

Drug: Avanafil

Study type

Interventional

Funder types

Industry

Identifiers

NCT00903981

CWP-AVA-301

Details and patient eligibility

About

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.

Enrollment

208 patients

Sex

Male

Ages

19 to 70 years old

Volunteers

No Healthy Volunteers

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