Clinical trial NCT00903981: Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of Avanafil
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Erectile Dysfunction
Lead sponsor: JW Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2009-05-19
Enrollment: 208
Sex: MALE
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change of EF domain score in the IIEF(The International Index of Erectile Function)
timeFrame: 12 weeks
Secondary outcomes:
measure: 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
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Chonju
country: Korea, Republic of
facility: Chonbuk national university hospital
state: Cholabukdo
Study officials:
affiliation: Chonbuk National University Hospital
name: Jong Kwan Park, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Catholic Seoul medical center
name: Se Woong Kim, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gyeongsang National University Hospital
name: Jae Suk Hyun, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Korea University
name: Je Jong Kim, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pusan National University Hospital
name: Nam Cheol Park, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Samsung Medical Center
name: Sung Won Lee, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National University Hospital
name: Jae Seung Paick, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Asan Medical Center
name: Tae young Ahn, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yeungnam University Hospital
name: Ki Hak Moon, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ewha womans university hospital
name: Woo Sik Chung, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Inje university Pusan paick hospital
name: Kweon Sik Min, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Inha University Hospital
name: Jun Kyu Suh, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chonnam National University Hospital
name: Kwang Sung Park, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kangdong Sacred Heart Hospital
name: Dae Yul Yang, PhD
role: PRINCIPAL_INVESTIGATOR
References: