Efficacy and Safety of Avanafil in the Patients With Erectile Dysfunction
Erectile Dysfunction
About this trial
This is an interventional treatment trial for Erectile Dysfunction
Eligibility Criteria
Inclusion Criteria:
- The male subjects who were aged 19 ~ 70 with history of erectile dysfunction for at least 6 months duration
- The subjects who had had stable monogamous relationships with their female partners
- Their partners were free from pregnancy and lactation and well prevent conception
- The subjects who were judged to be suitable to the clinical study in consequence of screening test
- The subjects who consented to participate in the clinical study in writing
- The subjects who attempted sexual intercourses at least 4 times in separate days during 4 weeks' free run-in period, and whose failure rate was over 50%.
- The subjects whose point were between 11 and 25 in EF domain of IIEF after 4 weeks' free run-in period
Exclusion Criteria:
The following cases were excluded from this clinical study.
- The subjects who had spinal cord injury or who underwent radical prostatectomy
- The subjects whose penises were anatomically deformed (Ex: server penile fibrosis, and Peyronie's disease)
The subjects who had erectile dysfunction due to neurogenic or endocrine cause (hyperprolactinemia, low serum testosterone levels, etc.)
- Hyperprolactinemia: serum prolactin over 3 times higher than the upper limit
- Low Testosterone: serum total testosterone less than the lower limit
- The subjects who had uncontrolled major psychiatric disorder and did not accept therapies (includes major depressions and schizophrenia) or had significant neurological abnormalities (neurovascular disorder)
- The subjects who underwent cancer chemotherapy within 1 year
- The subjects who were addicted to alcohol or who had continuously misused dependent drugs
The subjects who had hepatic dysfunction or renal dysfunction as in the following:
- Hepatic Dysfunction: GOT and GPT (glutamate-pyruvate transaminase) were three times higher than the upper limit
- Renal Dysfunction: serum creatinine was over 2.0mg/dl
- The subjects who had uncontrollable diabetes (FPG>180mg/dL)
- The subjects who had proliferative diabetic retinopathy
- The subjects who suffered from stroke, transient ischemic attacks, myocardial infarction, heart failure that needed to be medically treated, unstable angina or fatal arrhythmia or who underwent coronary artery bypass graft within 6 months
- The subjects had serious hypotension (SBP/DBP(diastolic blood pressure) is less than 90/50mmHg in a sitting posture) or uncontrollable severe hypertension (SBP/DBP is over 170/100mmHg in a sitting posture)
- The subjects who had hematological disorders that was likely to be developed into priapism such as sickle cell disease, multiple myeloma, leukemia
- The subjects who had retinitis pigmentosa
- The subjects who suffered from serious GI bleeding disorder within 1 year
- The subjects who took Viagra®, Cialis®, Levitra®, Mvix® and others within 2 weeks before the clinical study
The subjects who had taken the following drugs
① Nitrate/Nitric oxide(NO) donors(ex. Nitroglycerin, isosorbide mononitrate, amyl nitrate/nitrite, sodium nitroprusside)
② Androgens(ex testosterone), anti-androgen, trazodone
③ Anticoagulant (excludes antiplatelet drugs)
④ Erythromycin, itraconazole, ketoconazole, cimetidine, ritonavir, saquinavir, amprenavir, indinavir and nelfinavir that greatly affects CYP3A4 (cytochrome P450 isoenzyme 3A4)
- The subjects who had history of hypersensitivity to the PDE(phosphodiesterase)-5 inhibitors or whose erectile dysfunction was not improved
- The subjects who had hypoactive sexual desire
- The subjects who had no intention of having sexual intercourses 4 times in separate days during 4 weeks' free run-in period
- The subjects who took other study drugs within 30 days before this clinical study
- The subjects who were judged to be unsuitable to the clinical study by other reasons
Sites / Locations
- Department of Urology, Pusan National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Placebo Comparator
Avanafil 50mg group
Avanafil 100mg group
Avanafil 200mg group
Placebo group
Avanafil 50mg tablet + Placebo 100mg tablet
Avanafil 100mg tablet + Placebo 100mg tablet
Avanafil 100mg 2 tablets
Placebo 100mg 2tablets