Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of Avanafil

NCT00903981 | Completed Phase 3

• 1 other identifier: CWP-AVA-301
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

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.

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

• Change of EF domain score in the IIEF(The International Index of Erectile Function)

  12 weeks

Secondary Outcomes (1)

• 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

Study Arms (3)

Avanafil 100mg

EXPERIMENTAL

Drug: Avanafil

Avanafil 200mg

EXPERIMENTAL

Drug: Avanafil

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Avanafil DRUG

2 tablets(Avanafil 100mg tablet + Placebo 200mg tablet), 30 minutes before sexual intercourse

Avanafil 100mg

Placebo DRUG

2 Tablets(Placebo 100mg tablet + Placebo 200mg tablet), 30 minutes before sexual intercourse

Placebo

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• JW Pharmaceutical: lead

Study Sites (1)

Chonbuk national university hospital

Jeonju, Cholabukdo, 561-712, South Korea

Location

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

avanafil

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 18, 2009
• First Posted: May 19, 2009
• Study Start: March 1, 2009
• Primary Completion: October 1, 2009
• Study Completion: November 1, 2009
• Last Updated: April 23, 2010

Record last verified: 2009-02

Locations

KR (1)