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Randomized, active-controlled, comparative phase 3 efficacy and safety equivalence trial of Ovaleap® (recombinant human follicle-stimulating hormone) in infertile women using assisted reproduction technology (ART)

BACKGROUND: Pharmacokinetic studies with XM17 (Ovaleap®), a recombinant human follicle-stimulating hormone (r-hFSH, follitropin alfa), have demonstrated good safety and tolerability in healthy women whose endogenous FSH levels were down-regulated with a long agonist protocol. In these studies, Ovale...

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Detalles Bibliográficos
Autores principales: Strowitzki, Thomas, Kuczynski, Waldemar, Mueller, Arnd, Bias, Peter
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4702416/
https://www.ncbi.nlm.nih.gov/pubmed/26733057
http://dx.doi.org/10.1186/s12958-015-0135-8