Efficacy and Safety of TPN171H in the Patients With Erectile Dysfunction

Summary

This is an exploratory clinical study to presume the optimum usage and dosage for a therapeutic confirmatory study by evaluating the efficacy and safety of TPN171H 5mg, 10mg, 20mg or placebo administered orally in patients with erectile dysfunction. In conclusions, Patients with erectile dysfunction (ED) were administered placebo, TPN171H 5mg, 10mg or 20mg 30 minutes to 4 hours before sexual intercourse for 8 weeks.

Timeline

Start

2020-07-23

Primary completion

2021-07-26

Completion

2021-07-26

Outcome

Met primary endpoint

paper doses of 5, 10, and 20 mg of simenafil exhibited substantial increases than placebo in IIEF-EF score (9.7, 9.2, 9.5 vs. 5.5, P < .001) PMID 42114123 ↗

Publications

• Yang Y, Jiang T, Zhao L, Zhang X, Deng J, Dai Y, Zhou H, Juan J, Duan H, Jiang H. Efficacy and safety of simenafil in men with erectile dysfunction: a multicenter, randomized, double-blind, placebo-controlled, fixed dose, parallel group, phase 2 trial. J Sex Med. 2026 May 9;23(6):qdag075. doi: 10.1093/jsxmed/qdag075.

Drugs

Indications