{"id":"topical-testosterone-gel-1-62","safety":{"commonSideEffects":[{"rate":"null","effect":"Application site reactions"},{"rate":"null","effect":"Gynecomastia"},{"rate":"null","effect":"Acne"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"groq-llama-8b","explanation":"This is achieved by the topical application of a gel containing 1.62% testosterone, which is then absorbed through the skin and into the bloodstream, allowing for increased levels of testosterone to be available for the body to use.","oneSentence":"Topical testosterone gel 1.62% works by delivering testosterone through the skin to increase androgen levels in the body.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:39:21.459Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Treatment of hypogonadism in adult males"}]},"trialDetails":[{"nctId":"NCT06084338","phase":"PHASE2","title":"Randomized Phase II Trial of Targeted Radiation With no Castration for Mcrpc","status":"RECRUITING","sponsor":"VA Office of Research and Development","startDate":"2023-12-14","conditions":"Prostate Cancer","enrollment":60},{"nctId":"NCT05825092","phase":"PHASE2","title":"Effects of Early Testosterone Gel Administration on Physical Performance in the Critically Ill","status":"RECRUITING","sponsor":"University Hospital, Clermont-Ferrand","startDate":"2023-07-21","conditions":"Critical Illness","enrollment":600},{"nctId":"NCT03198728","phase":"PHASE3","title":"Efficacy and Safety of Oral Testosterone Undecanoate in Hypogonadal Men","status":"COMPLETED","sponsor":"Marius Pharmaceuticals","startDate":"2017-07-05","conditions":"Hypogonadism, Male","enrollment":314},{"nctId":"NCT04274894","phase":"PHASE4","title":"A Study of the Effect of Topical Testosterone Replacement Therapy on Blood Pressure in Adult Male Participants With Hypogonadism","status":"COMPLETED","sponsor":"AbbVie","startDate":"2020-05-12","conditions":"Hypogonadism","enrollment":246},{"nctId":"NCT02081300","phase":"PHASE3","title":"Safety and Efficacy of Oral LPCN 1021 in Men With Low Testosterone or Hypogonadism","status":"COMPLETED","sponsor":"Lipocine Inc.","startDate":"2014-02","conditions":"Male Hypogonadism","enrollment":315},{"nctId":"NCT02110368","phase":"PHASE3","title":"Bioequivalence Study of Test and Reference Testosterone Topical Gel, 1.62% Metered Pump in Testosterone Deficient Adult Male Subjects Under Fasting Conditions","status":"COMPLETED","sponsor":"Amneal Pharmaceuticals, LLC","startDate":"2014-03","conditions":"Primary Hypogonadism, Hypogonadotropic Hypogonadism","enrollment":32}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":1,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"Topical testosterone gel 1.62 %","genericName":"Topical testosterone gel 1.62 %","companyName":"Lipocine Inc.","companyId":"lipocine-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Topical testosterone gel 1.62% is a small molecule androgen receptor agonist, classified as an agonist. It is used to treat conditions such as hypogonadism, primary hypogonadism, and hypogonadotropic hypogonadism, and has been studied for its effects on physical performance in critically ill patients.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}