{"id":"testosterone-undecanoate-and-or-pde-5","safety":{"commonSideEffects":[{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Flushing"},{"rate":null,"effect":"Dyspepsia"},{"rate":null,"effect":"Nasal congestion"},{"rate":null,"effect":"Polycythemia"},{"rate":null,"effect":"Gynecomastia"},{"rate":null,"effect":"Acne"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Testosterone undecanoate is a long-acting androgen replacement therapy that restores physiological testosterone levels in hypogonadal men. PDE-5 inhibitors (such as sildenafil, tadalafil, or vardenafil) block phosphodiesterase-5 enzyme, preventing degradation of cGMP and promoting smooth muscle relaxation and vasodilation in the corpus cavernosum. The combination addresses both hormonal deficiency and erectile dysfunction.","oneSentence":"Testosterone undecanoate replaces deficient testosterone while PDE-5 inhibitors enhance erectile function by increasing nitric oxide signaling in penile vasculature.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:11:49.887Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hypogonadism with erectile dysfunction"},{"name":"Testosterone deficiency in adult males"}]},"trialDetails":[{"nctId":"NCT00555087","phase":"PHASE4","title":"Treatment of Erectile Dysfunction in Hypogonadal Men With Testosterone Undecanoate","status":"UNKNOWN","sponsor":"Hospital Santa Fe","startDate":"2007-05","conditions":"Erectile Dysfunction, Hypogonadotrophic Males","enrollment":50}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":1886,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Nebido","Levitra"],"phase":"marketed","status":"active","brandName":"Testosterone Undecanoate and/or PDE-5","genericName":"Testosterone Undecanoate and/or PDE-5","companyName":"Hospital Santa Fe","companyId":"hospital-santa-fe","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Testosterone undecanoate replaces deficient testosterone while PDE-5 inhibitors enhance erectile function by increasing nitric oxide signaling in penile vasculature. Used for Hypogonadism with erectile dysfunction, Testosterone deficiency in adult males.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}