{"id":"luveris-fixed-dose","safety":{"commonSideEffects":[{"rate":null,"effect":"Ovarian hyperstimulation syndrome (OHSS)"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Injection site reactions"},{"rate":null,"effect":"Abdominal pain/discomfort"},{"rate":null,"effect":"Nausea"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Luveris provides exogenous LH activity to support the late stages of follicular development and estrogen production during controlled ovarian hyperstimulation. It is typically used in combination with follicle-stimulating hormone (FSH) in women with LH deficiency or in specific ovarian stimulation protocols. The fixed-dose formulation combines LH and FSH in a predetermined ratio for convenience in fertility treatment.","oneSentence":"Luveris is a recombinant luteinizing hormone (LH) that stimulates ovarian steroidogenesis and follicle development in women undergoing assisted reproductive technology.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-27T23:53:44.294Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Infertility in women with profound LH and FSH deficiency undergoing assisted reproductive technology"},{"name":"Controlled ovarian hyperstimulation in women with LH deficiency during in vitro fertilization (IVF)"}]},"trialDetails":[{"nctId":"NCT07269327","phase":"PHASE1","title":"An Ethno-bridging Study of Pergoveris in Healthy Premenopausal Participants of Japanese or Caucasian Origin","status":"COMPLETED","sponsor":"Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany","startDate":"2025-11-24","conditions":"Fertility","enrollment":24},{"nctId":"NCT07340827","phase":"PHASE3","title":"A Study to Compare the Efficacy and Safety of Follitropin Alfa/Lutropin Alfa Versus hMG in Japanese Participants With LH and FSH Deficiency Undergoing ART (HINATA)","status":"RECRUITING","sponsor":"Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany","startDate":"2026-02-05","conditions":"Infertility","enrollment":333},{"nctId":"NCT04899193","phase":"PHASE1","title":"Pergoveris FD and Liquid China BE Study","status":"COMPLETED","sponsor":"Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany","startDate":"2021-05-08","conditions":"Healthy","enrollment":72},{"nctId":"NCT00889512","phase":"PHASE4","title":"The Luveris In Vitro Fertilization Trial","status":"TERMINATED","sponsor":"University Reproductive Associates","startDate":"2009-04","conditions":"Infertility, Hypothalamic Amenorrhea, Hyperprolactinemia","enrollment":14},{"nctId":"NCT02108223","phase":"PHASE4","title":"The Evaluation of Recombinant LH Supplementation in Patients With Suboptimal Response to Recombinant FSH Undergoing ICSI","status":"COMPLETED","sponsor":"Sisli Hamidiye Etfal Training and Research Hospital","startDate":"2009-01","conditions":"Infertility","enrollment":137},{"nctId":"NCT00328926","phase":"PHASE4","title":"Luveris® (Lutropin Alfa for Injection) in Women With Hypogonadotropic Hypogonadism (Luteinizing Hormone [LH] Less Than [<] 1.2 International Unit Per Liter [IU/L])","status":"TERMINATED","sponsor":"EMD Serono","startDate":"2006-03","conditions":"Hypogonadotropic Hypogonadism","enrollment":11}],"_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":"marketed","status":"active","brandName":"Luveris fixed dose","genericName":"Luveris fixed dose","companyName":"University Reproductive Associates","companyId":"university-reproductive-associates","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Luveris is a recombinant luteinizing hormone (LH) that stimulates ovarian steroidogenesis and follicle development in women undergoing assisted reproductive technology. Used for Infertility in women undergoing assisted reproductive technology (ART) with LH deficiency, Controlled ovarian hyperstimulation in ART cycles.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}