Drugs / Pergoveris

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Pergoveris 2007-06-25 europa.eu

Trials 5 · a red edge is where a trial was stopped

200720082009201020112012201320142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT04899193 May 2021 → May 2022 Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany Completed No outcome recorded
Phase 32 trials
Phase 3 NCT02047227 Jan 2014 → Aug 2015 infertility disorder Merck KGaA, Darmstadt, Germany Completed No outcome recorded
Phase 3 NCT01297465 May 2011 → Oct 2012 Merck KGaA, Darmstadt, Germany Completed No outcome recorded
Phase 41 trial
Phase 4 NCT03400722 Dec 2017 → Aug 2018 female infertility, ovarian hyperstimulation syndrome Nova Clinic, Russia Unknown No outcome recorded
Phase not applicable1 trial
NCT01623570 Mar 2011 → May 2012 hypogonadotropic hypogonadism Centro Riproduzione e Andrologia Completed No outcome recorded
Also used as a comparator or background therapy in 2 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 41 trial
Phase 4 NCT02992808 Comparator Dec 2016 → Jan 2018 female infertility Sheba Medical Center Unknown No outcome recorded
Phase not applicable1 trial
NCT01565265 Comparator Apr → Dec 2012 female infertility University Hospital, Basel, Switzerland Completed No outcome recorded

Evidence & citations 6 cited values

Every value below carries the sentence it was read from. 8 sources stand behind the page.

FieldValueCited text
Known as Pergoveris “As the recombinant preparation we will use Pergoveris© (follitropin alfa/lutropin alfa, MERCK SERONO) which contains 150 units of FSH + 75 units of LH and Luveris© (lutropin...” NCT02992808
6

NCT01297465

NCT02047227

NCT03400722

NCT01623570

NCT04899193

NCT01565265

Known as follitropin alfa/lutropin alfa “Pergoveris© (follitropin alfa/lutropin alfa, MERCK SERONO) which contains 150 units of FSH + 75 units of LH” NCT02992808
Known as Pergoveris FD “Drug: Pergoveris FDNCT04899193
Known as Pergoveris Liquid “Drug: Pergoveris LiquidNCT04899193
Modality Protein / enzyme biologic “recombinant human FSH (rhFSH) plus recombinant human luteinizing hormone (rhLH)” PMID 26194884 Jun 2015
Route Subcutaneous “Pergoveris® (follitropin alfa and lutropin alfa) 300 IU will be administered subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG)...” NCT01297465