{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,11]],"date-time":"2025-10-11T01:33:27Z","timestamp":1760146407781,"version":"build-2065373602"},"reference-count":36,"publisher":"MDPI AG","issue":"21","license":[{"start":{"date-parts":[[2024,10,31]],"date-time":"2024-10-31T00:00:00Z","timestamp":1730332800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Iuliu Ha\u021bieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania","award":["1032\/73\/13.01.2021","882\/64\/12.01.2022"],"award-info":[{"award-number":["1032\/73\/13.01.2021","882\/64\/12.01.2022"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCM"],"abstract":"<jats:p>Background: Tadalafil cream, a topically administered phosphodiesterase-5 inhibitor (PDE5), presents a potential alternative to oral PDE5 inhibitors like tadalafil for the treatment of erectile dysfunction (ED). This study evaluates the non-inferiority and potential superiority of tadalafil cream compared to oral tadalafil. Methods: This randomized controlled trial employed a cross-over design with two treatment periods of two weeks each, separated by a one-week washout phase. Thirty-five male participants aged 18\u201375 with diagnosed ED (International Index of Erectile Function\u2013Erectile function: IIEF-EF score &lt; 26) were randomized to receive either tadalafil cream or oral tadalafil. Tadalafil cream was applied topically, while tadalafil was taken orally. The primary endpoint was IIEF-EF, and secondary endpoints were measured using the International Index of Erectile Function (IIEF) domain scores. Adverse events and treatment preferences were also assessed. Results: Tadalafil cream showed a higher increase in sexual function across all IIEF domains compared to oral tadalafil. The lower bounds of the confidence interval [improvement: final\u2212baseline scores between tadalafil cream and oral tadalafil 0.72 (95% CI \u22122.72\u20134.15)] were above the non-inferiority margin of \u22123.22, confirming tadalafil cream\u2019s non-inferiority in the erectile function domain. In the intercourse satisfaction domain, tadalafil cream was superior to oral tadalafil. At the end of the trial, 88.57% of participants preferred tadalafil cream (95% CI 73.26%\u201396.79%), a result significantly above the non-inferiority margin that indicated superiority (p &lt; 0.001). No systemic adverse events were reported for tadalafil cream, and significant differences in dizziness, headache, nasal congestion, and erythema were observed between the two treatments. Conclusions: Tadalafil cream is a safe and effective treatment for erectile dysfunction, demonstrating non-inferiority and potential superiority over oral tadalafil, with a high patient preference. Its topical administration offers a promising alternative for patients, particularly those with cardiovascular diseases where oral PDE5 inhibitors are contraindicated or less well tolerated.<\/jats:p>","DOI":"10.3390\/jcm13216557","type":"journal-article","created":{"date-parts":[[2024,11,1]],"date-time":"2024-11-01T11:53:43Z","timestamp":1730462023000},"page":"6557","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["The Intra-Meatal Application of Tadalafil Cream Versus Oral Administration Efficacy and Safety: Results from a Randomized, Two-Administration Route, Cross-Over Clinical Trial"],"prefix":"10.3390","volume":"13","author":[{"ORCID":"https:\/\/orcid.org\/0009-0004-9318-4036","authenticated-orcid":false,"given":"Drago\u0219-Mihail","family":"Trifu","sequence":"first","affiliation":[{"name":"Department of Urology, Iuliu Ha\u021bieganu University of Medicine and Pharmacy, 400012 Cluj-Napoca, Romania"},{"name":"Department of Urology, Municipal Blaj Hospital, 515400 Blaj, Romania"},{"name":"Department of Urology, Endoplus Clinic, 400165 Cluj-Napoca, Romania"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4218-8622","authenticated-orcid":false,"given":"Daniel-Corneliu","family":"Leucu\u021ba","sequence":"additional","affiliation":[{"name":"Department of Medical Informatics and Biostatistics, Iuliu Ha\u021bieganu University of Medicine and Pharmacy, 400349 Cluj-Napoca, Romania"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8801-5407","authenticated-orcid":false,"given":"Martina-Luciana","family":"Pintea-Trifu","sequence":"additional","affiliation":[{"name":"Department of Cellular and Molecular Biology, Iuliu Ha\u021bieganu University of Medicine and Pharmacy, 400349 Cluj-Napoca, Romania"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Florin","family":"Elec","sequence":"additional","affiliation":[{"name":"Department of Urology, Iuliu Ha\u021bieganu University of Medicine and Pharmacy, 400012 Cluj-Napoca, Romania"},{"name":"Clinical Institute of Urology and Renal Transplantation, Iuliu Ha\u021bieganu University of Medicine and Pharmacy, 400000 Cluj-Napoca, Romania"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nicolae","family":"Cri\u0219an","sequence":"additional","affiliation":[{"name":"Department of Urology, Iuliu Ha\u021bieganu University of Medicine and Pharmacy, 400012 Cluj-Napoca, Romania"},{"name":"Department of Urology, Municipal Cluj Hospital, Iuliu Ha\u021bieganu University of Medicine and Pharmacy, 400139 Cluj-Napoca, Romania"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dan","family":"Eniu","sequence":"additional","affiliation":[{"name":"Department of Surgical Oncology, Iuliu Ha\u021bieganu University of Medicine and Pharmacy, 400000 Cluj-Napoca, Romania"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ioan","family":"Coman","sequence":"additional","affiliation":[{"name":"Department of Urology, Iuliu Ha\u021bieganu University of Medicine and Pharmacy, 400012 Cluj-Napoca, Romania"},{"name":"Department of Urology, Endoplus Clinic, 400165 Cluj-Napoca, Romania"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2024,10,31]]},"reference":[{"key":"ref_1","unstructured":"(2024, October 19). 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