Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of Avanafil

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

Interventions

DRUG

Avanafil

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

DRUG

Avanafil

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

DRUG

Placebo

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

Sponsors & Collaborators

• JW Pharmaceutical

  lead INDUSTRY

Principal Investigators

• Jong Kwan Park, PhD · Chonbuk National University Hospital

• Se Woong Kim, PhD · Catholic Seoul medical center

• Jae Suk Hyun, PhD · Gyeongsang National University Hospital

• Je Jong Kim, PhD · Korea University

• Nam Cheol Park, PhD · Pusan National University Hospital

• Sung Won Lee, PhD · Samsung Medical Center

• Jae Seung Paick, PhD · Seoul National University Hospital

• Tae young Ahn, PhD · Asan Medical Center

• Ki Hak Moon, PhD · Yeungnam University Hospital

• Woo Sik Chung, PhD · Ewha womans university hospital

• Kweon Sik Min, PhD · Inje university Pusan paick hospital

• Jun Kyu Suh, PhD · Inha University Hospital

• Kwang Sung Park, PhD · Chonnam National University Hospital

• Dae Yul Yang, PhD · Kangdong Sacred Heart Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

19 Years

Max Age

70 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-03-31

Primary Completion

2009-10-31

Completion

2009-11-30

Countries

• South Korea

Study Locations