{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,11]],"date-time":"2026-09-11T14:12:30Z","timestamp":1789135950281,"version":"build-2803163510"},"reference-count":20,"publisher":"Ovid Technologies (Wolters Kluwer Health)","content-domain":{"domain":["lww.com","ovid.com"],"crossmark-restriction":true},"short-container-title":[],"abstract":"<jats:p>\n                    Simenafil, a newly developed oral phosphodiesterase type 5 (PDE5) inhibitor, substantially improves erectile function; however, its efficacy has not been evaluated via RigiScan monitoring. This study evaluated the efficacy and safety of simenafil in erectile dysfunction (ED) using audiovisual sexual stimulation. A randomized, double-blind, placebo-controlled, multicenter, two-cohort, three-way crossover study was conducted in 84 men aged 18\u201365 years with mild-to-moderate ED of \u22656 months. Each patient received placebo, simenafil 5.0 mg, and simenafil 2.5 mg (Cohort A,\n                    <jats:italic toggle=\"yes\">n<\/jats:italic>\n                    = 42) or 10.0 mg (Cohort B,\n                    <jats:italic toggle=\"yes\">n<\/jats:italic>\n                    = 42) administered in random order at least 5 days apart. RigiScan was used to assess the time to achieve and duration of \u226560% penile rigidity. In Cohort A, relative to placebo, 2.5 mg simenafil (single-dose) led to a least square mean (LSM) increase in the duration of \u226560% penile rigidity of 3.1 min (95% confidence interval [CI]: 0.5\u20135.7 min,\n                    <jats:italic toggle=\"yes\">P<\/jats:italic>\n                    = 0.021) and 8.3 min (95% CI: 3.5\u201313.2 min,\n                    <jats:italic toggle=\"yes\">P<\/jats:italic>\n                    = 0.001) at the tip and base, respectively; for the 5.0 mg, it was 3.7 min (95% CI: 1.0\u20136.4 min,\n                    <jats:italic toggle=\"yes\">P<\/jats:italic>\n                    = 0.008) and 8.5 min (95% CI: 3.5\u201313.5 min,\n                    <jats:italic toggle=\"yes\">P<\/jats:italic>\n                    = 0.001) at the tip and base, respectively. In Cohort B, the LSM duration of \u226560% rigidity of the penile base was significantly longer with 10.0 mg simenafil than with placebo by 5.9 min (95% CI: 0.8\u201310.9 min,\n                    <jats:italic toggle=\"yes\">P<\/jats:italic>\n                    = 0.023). The 5.0 mg (tip and base) and 10.0 mg (tip) simenafil were not statistically significant compared with the placebo (all\n                    <jats:italic toggle=\"yes\">P<\/jats:italic>\n                    &gt; 0.05). The pharmacodynamic and safety profiles support simenafil as a suitable candidate for further investigation in ED.\n                  <\/jats:p>","DOI":"10.4103\/aja202622","type":"journal-article","created":{"date-parts":[[2026,9,11]],"date-time":"2026-09-11T14:00:13Z","timestamp":1789135213000},"update-policy":"https:\/\/doi.org\/10.1097\/lww.0000000000001000","source":"Crossref","is-referenced-by-count":0,"title":["Efficacy and safety of simenafil in erectile dysfunction: a phase II, randomized, double-blind, placebo-controlled, crossover study"],"prefix":"10.4103","author":[{"given":"Zhe","family":"Zhang","sequence":"first","affiliation":[{"name":"Department of Urology, Center for Reproductive Medicine, Peking University Third Hospital, Beijing 100191, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tao","family":"Jiang","sequence":"additional","affiliation":[{"name":"Department of Andrology and Sexual Medicine, Institute of Sexual Medicine, The Second Hospital of Dalian Medical University, Dalian 116023, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yu-Tian","family":"Dai","sequence":"additional","affiliation":[{"name":"Department of Andrology, Nanjing Drum Tower Hospital, Nanjing 21008, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xian-Sheng","family":"Zhang","sequence":"additional","affiliation":[{"name":"Department of Urology, The First Affiliated Hospital of Anhui Medical University, Hefei 230022, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yu-Hua","family":"Huang","sequence":"additional","affiliation":[{"name":"Department of Urology, The First Affiliated Hospital of Soochow University, Suzhou 215006, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiang-Sheng","family":"Zhang","sequence":"additional","affiliation":[{"name":"Department of Urology and Andrology, Henan Provincial People\u2019s Hospital, Zhengzhou 450003, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hui-Liang","family":"Zhou","sequence":"additional","affiliation":[{"name":"Department of Andrology and Sexual Medicine, First Affiliated Hospital of Fujian Medical University, Fuzhou 350005, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jia-Xiang","family":"Juan","sequence":"additional","affiliation":[{"name":"Vigonvita Life Sciences Co., Ltd., Suzhou 215123, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hua-Qing","family":"Duan","sequence":"additional","affiliation":[{"name":"Vigonvita Life Sciences Co., Ltd., Suzhou 215123, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hui","family":"Jiang","sequence":"additional","affiliation":[{"name":"Department of Urology, Peking University First Hospital, Beijing 100034, China"},{"name":"Institute of Urology, Peking University, Beijing 100034, China"},{"name":"Beijing Key Laboratory of Urogenital 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