Efficacy and Safety of Avanafil in Chinese Subjects With Erectile Dysfunction: A Multi-Center, Randomized, Double-Blinded, Placebo-Controlled Phase III Clinical Trial

Hui Jiang, MD, PhD; Haocheng Lin, MD, PhD; Fubiao Li, MD; Yutian Dai, MD, PhD; Xiangsheng Zhang, MD, PhD; Tao Jiang, MD, PhD; Junhong Deng, MD, PhD

Sexual Medicine (Jun 2021)

Efficacy and Safety of Avanafil in Chinese Subjects With Erectile Dysfunction: A Multi-Center, Randomized, Double-Blinded, Placebo-Controlled Phase III Clinical Trial

Hui Jiang, MD, PhD,
Haocheng Lin, MD, PhD,
Fubiao Li, MD,
Yutian Dai, MD, PhD,
Xiangsheng Zhang, MD, PhD,
Tao Jiang, MD, PhD,
Junhong Deng, MD, PhD

Affiliations

Hui Jiang, MD, PhD: Department of Urology, Peking University Third Hospital, Beijing, China; Department of Reproductive Medicine Center, Peking University Third Hospital, Beijing, China; Department of Andrology, Peking University Third Hospital, Beijing, China
Haocheng Lin, MD, PhD: Department of Urology, Peking University Third Hospital, Beijing, China; Department of Reproductive Medicine Center, Peking University Third Hospital, Beijing, China; Department of Andrology, Peking University Third Hospital, Beijing, China
Fubiao Li, MD: Department of Andrology, The First Hospital of Jilin University, Changchun, Jilin, China
Yutian Dai, MD, PhD: Department of Andrology and Sexual Medicine, The Affiliated Drum Tower Hospital of Nanjing University School of Medicine, Nanjing, China
Xiangsheng Zhang, MD, PhD: Department of Andrology, Henan Provincial People's Hospital, Henan University People's Hospital, Zhengzhou, Henan, China
Tao Jiang, MD, PhD: Department of Urology and Andrology, The First Affiliated Hospital, Dalian Medical University, Dalian, Liaoning, China; Corresponding Authors: Tao Jiang, MD, PhD, Department of Urology and Andrology, The First Affiliated Hospital, Dalian Medical University, Dalian, Liaoning, 116011, China.
Junhong Deng, MD, PhD: Department of Andrology, Guangzhou First People's Hospital, The Second Affiliated Hospital of South China University of Technology, Guangzhou, China; Junhong Deng, MD, PhD, Department of Andrology, Guangzhou First People's Hospital, The Second Affiliated Hospital of South China University of Technology, Guangzhou 510180, China.

Journal volume & issue: Vol. 9, no. 3
p. 100337

Abstract

Read online

Introduction: The incidence of erectile dysfunction (ED) increases with age in mainland China and phosphodiesterase 5 inhibitors (PDE5i) are the major drugs used for its treatment. Aim: To determine the efficacy and safety of Chinese developed avanafil as therapy for ED in China. Methods: This phase III trial was carried out in 7 medical centers in China. Eligible subjects suffering from ED were allocated randomly into 3 groups (ratio 1:1:1) and orally received a placebo, 100 or 200 mg avanafil for a total of 12 weeks. Main outcome measures: The primary endpoint was changes in erectile function (EF) domain scores according to the International Index of EF (IIEF) questionnaire from baseline to week 12 of therapy. Secondary endpoints assessments were changes in the response rates of SEP, Q2 and Q3; changes in IIEF other domain scores. Safety evaluation monitored treatment-emergent adverse events (TEAEs), serious TEAEs, laboratory test results, vital signs and electrocardiographs. Results: Of 218 randomized ED subjects, 182 (83.5%) completed the study. After 12-week therapy, alterations from baseline of the mean IIEF-EF domain scores in the 100 mg and 200 mg groups were greater than for the placebo (all P .05) or in the incidence of TEAEs and drug-related TEAEs among the 3 groups (all P > .05). Conclusion: Avanafil (100 or 200 mg) was effective and generally well tolerated in Chinese subjects with ED.Jiang H, Lin H, Li F, et al. Efficacy and Safety of Avanafil in Chinese Subjects With Erectile Dysfunction: A Multi-Center, Randomized, Double-Blinded, Placebo-Controlled Phase III Clinical Trial. Sex Med 2021;9:100337.

Published in Sexual Medicine

ISSN: 2050-1161 (Online)
Publisher: Oxford University Press
Country of publisher: United Kingdom
LCC subjects: Medicine
Website: https://academic.oup.com/smoa

About the journal

Abstract

Keywords