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Original Research

Phase 1 safety, tolerability, and pharmacokinetic study of single ascending doses of XM17 (recombinant human follicle-stimulating hormone) in downregulated healthy women

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Pages 707-716 | Published online: 16 Jul 2015

References

  • DhillonSKeatingGMLutropin alfaDrugs200868111529154018627209
  • DurocherYButlerMExpression systems for therapeutic glycoprotein productionCurr Opin Biotechnol200920670070719889531
  • le CotonnecJYPorchetHCBeltramiVKhanAToonSRowlandMClinical pharmacology of recombinant human follicle-stimulating hormone (FSH). I. Comparative pharmacokinetics with urinary human FSHFertil Steril19946146696788150109
  • ChambostHLjungRChanging pattern of care of boys with haemophilia in western European centresHaemophilia2005112929915810909
  • DayaSFollicle-stimulating hormone in clinical practice: an updateTreat Endocrinol20043316117116026112
  • van WelyMKwanIBurtALRecombinant versus urinary gonadotrophin for ovarian stimulation in assisted reproductive technology cyclesCochrane Database Syst Rev20112CD00535421328276
  • Recombinant Human FSH Product Development GroupRecombinant follicle stimulating hormone: development of the first biotechnology product for the treatment of infertilityHum Reprod Update19984686288110098477
  • HuirneJALambalkCBvan LoenenACContemporary pharmacological manipulation in assisted reproductionDrugs200464329732214871171
  • ReichlHBalenAJansenCAPrion transmission in blood and urine: what are the implications for recombinant and urinary-derived gonadotrophins?Hum Reprod200217102501250812351519
  • HarrisonSWolfTAbuzeidMIAdministration of recombinant follicle stimulating hormone in a woman with allergic reaction to menotropin: a case reportGynecol Endocrinol200014314915210923273
  • EscobarMAHealth economics in haemophilia: a review from the clinician’s perspectiveHaemophilia201016Suppl 3293420586799
  • European Medicines AgencyOvaleap (follitropin alfa) [assessment report]7312013 Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002608/WC500152908.pdfAccessed February 25, 2015
  • Gonal-f® [summary of product characteristics]London, UKEuropean Medicines Agency2010
  • Puregon [summary of product characteristics]London, UKEuropean Medicines Agency2006
  • Bemfola (follitropin alfa) [summary of product characteristics]London, UKEuropean Medicines Agency2014
  • MattaWHShawRWBurfordGDEndocrinologic and clinical evaluation following a single administration of a gonadotrophin-releasing hormone agonist (Zoladex), in a depot formulation, to premenopausal womenFertil Steril19884911631652961621
  • Gonal-f® 75 IU (5.5 micrograms) powder and solvent for solution for injection [package insert]London, UKMerck Serono Europe Ltd2012
  • le CotonnecJYPorchetHCBeltramiVKhanAToonSRowlandMClinical pharmacology of recombinant human follicle-stimulating hormone. II. Single doses and steady state pharmacokineticsFertil Steril19946146796868150110
  • LuganIFebbraroSLecuelleHPapasouliotisOHo-NguyenaQBuraglioMBioequivalence of liquid and freeze-dried recombinant human follicle-stimulating hormoneCurr Med Res Opin200521112112515881483
  • GertzBLammerichAPhase I Study to establish the bioequivalence of recombinant human follicle stimulating hormone (r-hFSH; XM17) to Gonal-f® (follitropin alfa) in downregulated healthy female subjectsAbstract presented at the 10th Congress of the European Society of GynecologySeptember 18–21, 2013Brussels, Belgium
  • GertzBBiasPLammerichAPhase I dose-ranging study of a recombinant human follicle-stimulating hormone (rhFSH) in healthy female volunteersHum Reprod201429Suppl 1i319i320 Abstr P-486