{"id":"letrozol-step-up-dose","safety":{"commonSideEffects":[{"rate":"20–30","effect":"Hot flashes"},{"rate":"20–25","effect":"Arthralgia/joint pain"},{"rate":"10–20","effect":"Fatigue"},{"rate":"10–15","effect":"Headache"},{"rate":"10–15","effect":"Nausea"},{"rate":null,"effect":"Osteoporosis/bone loss"},{"rate":"10–15","effect":"Elevated cholesterol"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Letrozole selectively inhibits the aromatase enzyme (CYP19A1), which catalyzes the final step of estrogen biosynthesis in peripheral tissues. By reducing estrogen availability, it suppresses the growth of estrogen-dependent breast cancer cells. The 'step up dose' formulation likely refers to a dose-escalation protocol being evaluated in this Phase 3 trial.","oneSentence":"Letrozole is an aromatase inhibitor that blocks the conversion of androgens to estrogen, reducing circulating estrogen levels in postmenopausal women.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:18:42.157Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hormone receptor-positive, HER2-negative breast cancer in postmenopausal women (adjuvant or metastatic setting)"}]},"trialDetails":[{"nctId":"NCT07143682","phase":"PHASE3","title":"Letrozole Step up Protocol for Ovulation Induction in Infertile Women With Polycystic Ovary Syndrome","status":"COMPLETED","sponsor":"Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh","startDate":"2023-01-08","conditions":"Polycystic Ovarian Syndrome (PCOS), Infertility","enrollment":70},{"nctId":"NCT04069117","phase":"PHASE4","title":"Follicular Synchronization in PCOS Patients Undergoing ICSI","status":"COMPLETED","sponsor":"Mansoura University Hospital","startDate":"2019-08-01","conditions":"Polycystic Ovarian Syndrome","enrollment":200},{"nctId":"NCT01058252","phase":"","title":"Minimal Stimulation Protocol Using Aromek(Letrozole) and Follitrope(recFSH) Combined With INVOCell-Low Cost IVF","status":"UNKNOWN","sponsor":"Galaxy Pharma (Pvt) Limited","startDate":"2021-05","conditions":"Primary Infertility, Secondary Infertility, Low Responders","enrollment":30},{"nctId":"NCT04325295","phase":"NA","title":"LOD vs Gn in Anovulatory PCOs Resistant to First Line Agents","status":"UNKNOWN","sponsor":"Assiut University","startDate":"2020-12","conditions":"Polycystic Ovary Syndrome, Anovulation","enrollment":200}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"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":"Letrozol step up dose","genericName":"Letrozol step up dose","companyName":"Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh","companyId":"bangabandhu-sheikh-mujib-medical-university-dhaka-bangladesh","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Letrozole is a small molecule used to treat conditions such as Polycystic Ovarian Syndrome (PCOS) and infertility, particularly in women with anovulation. It is administered through a step-up dose protocol, which involves increasing the dosage of letrozole over time, as an alternative to a conventional fixed dose.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}