eprintid: 20075
rev_number: 11
eprint_status: archive
userid: 1589
dir: disk0/00/02/00/75
datestamp: 2016-02-17 09:25:54
lastmod: 2024-04-28 16:05:34
status_changed: 2016-02-17 09:25:54
type: article
metadata_visibility: show
creators_name: Strowitzki, Thomas
creators_name: Kuczynski, Waldemar
creators_name: Müller, Arnd
creators_name: Bias, Peter
title: 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)
subjects: ddc-610
divisions: i-910400
abstract: 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, Ovaleap® pharmacokinetics were dose-proportional and bioequivalent to the reference follitropin alfa product (Gonal-f®). The objective of the present study is to determine whether Ovaleap® is equivalent to Gonal-f® with respect to the number of oocytes retrieved in infertile but ovulatory women undergoing assisted reproductive technology (ART) therapy.   Methods: This multinational, multicenter, randomized (1:1), active-controlled, assessor-blind, comparative study included infertile normally gonadotrophic women 18 to 37 years old with a body mass index of 18 to 29 kg/m2 and regular menstrual cycles of 21 to 35 days undergoing ART therapy. During a 5-day fixed-dose phase, women received 150 IU/day of Ovaleap® (n = 153) or Gonal-f® (n = 146), followed by an up to 15-day dose-adaptation phase during which doses could be adjusted every 3 to 5 days, up to a maximum of 450 IU/day. Ovaleap® was to be deemed equivalent to Gonal-f® if the two-sided 0.95 confidence interval (CI) for the difference in the number of oocytes retrieved fell within the equivalence range of ±3 oocytes.   Results: Similar numbers of oocytes were retrieved in the 2 treatment groups. The mean ± SD number of oocytes retrieved was 12.2 ± 6.7 in the Ovaleap® group and 12.1 ± 6.7 in the Gonal-f® group (intent-to-treat [ITT] population). Regression analysis estimated a mean difference of 0.03 oocytes between the treatment groups (95 % CI: −0.76-0.82), which was well within the prespecified equivalence range of ±3 oocytes. Ovaleap® and Gonal-f® showed favorable and comparable safety profiles, with no unexpected safety findings.   Conclusions: Ovaleap® has shown the same efficacy and safety as Gonal-f® for stimulation of follicular development in infertile women (up to 37 years of age) who are undergoing ART therapy.   Trial Registration EudraCT: 2009-017674-20. Current controlled trials: ISRCTN74772901. Date of trial registration: 19 March 2010.
date: 2016
publisher: BioMed Central
id_scheme: DOI
ppn_swb: 1656587319
own_urn: urn:nbn:de:bsz:16-heidok-200753
language: eng
bibsort: STROWITZKIRANDOMIZED2016
full_text_status: public
publication: Reproductive Biology and Endocrinology
volume: 14
number: 1
place_of_pub: London
pagerange: 1-12
issn: 1477-7827
citation:   Strowitzki, Thomas ; Kuczynski, Waldemar ; Müller, Arnd ; Bias, Peter  (2016) 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).  Reproductive Biology and Endocrinology, 14 (1).  pp. 1-12.  ISSN 1477-7827     
document_url: https://archiv.ub.uni-heidelberg.de/volltextserver/20075/1/12958_2015_Article_135.pdf