J Korean Med Sci.  2017 Jun;32(6):1016-1023. 10.3346/jkms.2017.32.6.1016.

A Randomized, Placebo-Controlled, Double-Blind, Multi-Center Therapeutic Confirmatory Study to Evaluate the Safety and Efficacy of Avanafil in Korean Patients with Erectile Dysfunction

Affiliations
  • 1Department of Urology and Medical Research Institute of Pusan National University Hospital, Pusan National University School of Medicine, Busan, Korea. joon501@pusan.ac.kr
  • 2Department of Urology, College of Medicine, The Catholic University of Korea, Seoul, Korea.
  • 3Department of Urology, College of Medicine, Korea University, Seoul, Korea.
  • 4Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
  • 5Department of Urology, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Korea.
  • 6Department of Urology, Ulsan University College of Medicine, Asan Medical Center, Seoul, Korea.
  • 7Department of Urology, Chonnam National University Medical School, Gwangju, Korea.
  • 8Department of Urology, Chonbuk National University Medical School, Jeonju, Korea.

Abstract

A multi-center, randomized, double-blind, placebo-controlled study was conducted with 158 subjects who were randomized to placebo or avanafil 50, 100, and 200 mg on demand for 8 weeks to evaluate the safety, tolerability, and efficacy of avanafil in the treatment of erectile dysfunction (ED) in Korean men. The primary outcome was the erectile function (EF) domain score of the International Index of Erectile Function (IIEF) questionnaire. Secondary outcomes included changes in the scores of IIEF questions 3 and 4 (IIEF Q3, Q4) from baseline, changes in all domain scores in the IIEF from baseline, Sexual Encounter Profile questions 2-5 (SEP2-5), the Global Efficacy Assessment Question (GEAQ), and the number of subjects whose EF domain score at the 8th week visit was ≥ 26. After 8 weeks of treatment, the dose groups except avanafil 50 mg scored significantly higher on the IIEF-EF domain from baseline than the placebo group. The changes from baseline in the avanafil group in IIEF Q3 (all doses) and Q4 (200 mg alone) were higher than the placebo group. The differences between avanafil and placebo groups were significant in SEP2 (100 and 200 mg) and SEP3-5 (200 mg). The differences in the GEAQ "Yes" response were also significant in the avanafil 100 and 200 mg groups. Regarding the ratio of normal EF at the end of the study, avanafil 200 mg differed significantly from the placebo. Most treatment-associated adverse events were mild and resolved spontaneously. This is a clinical trial study and was registered at www.ClinicalTrials.gov (Identifier: NCT02477436).

Keyword

Erectile Dysfunction; Phosphodiesterase 5 Inhibitors; Penile Erection

MeSH Terms

Erectile Dysfunction*
Humans
Male
Penile Erection
Phosphodiesterase 5 Inhibitors
Phosphodiesterase 5 Inhibitors

Figure

  • Fig. 1 Study schedule (A) and patient disposition (B). ITT = intent-to-treat, PP = per protoccol.

  • Fig. 2 Effects of avanafil on reponses to IIEF Q3 (A) and IIEF Q4 (B) score at 8 weeks after the start of treatment. IIEF = International Index of Erectile Function, IIEF Q3 = International Index of Erectile Function questions 3, IIEF Q4 = International Index of Erectile Function questions 4. *P < 0.05 vs. placebo.

  • Fig. 3 Effects of avanafil on reponses to the SEP2 (A) and SEP3 (B) at 8 weeks after the start of treatment. SEP2 = Sexual Encounter Profile question 2, SEP3 = Sexual Encounter Profile question 3. *P < 0.05 vs. placebo, †P < 0.001 vs. placebo.


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