Multicenter, noninterventional, post-marketing surveillance study to evaluate dosing of recombinant human follicle-stimulating hormone using the redesigned follitropin alfa pen in women undergoing ovulation induction

Frank Nawroth,1 Andreas Tandler-Schneider,2 Wilma Bilger3 1Centre for Reproductive and Prenatal Medicine, Endocrinology and Osteology, Hamburg, Germany; 2Center for Reproductive Medicine, Fertility Center Berlin, Berlin, Germany; 3Medical Affairs, Fertility, Endocrinology and General Medicine, Merck...

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Main Authors: Nawroth F, Tandler-Schneider A, Bilger W
Format: Article
Language:English
Published: Dove Medical Press 2015-04-01
Series:Drug, Healthcare and Patient Safety
Online Access:http://www.dovepress.com/multicenter-noninterventional-post-marketing-surveillance-study-to-eva-peer-reviewed-article-DHPS
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spelling doaj-e5deeb31cb084a6da6f82ad15122dffa2020-11-25T01:12:46ZengDove Medical PressDrug, Healthcare and Patient Safety1179-13652015-04-012015default636821325Multicenter, noninterventional, post-marketing surveillance study to evaluate dosing of recombinant human follicle-stimulating hormone using the redesigned follitropin alfa pen in women undergoing ovulation inductionNawroth FTandler-Schneider ABilger WFrank Nawroth,1 Andreas Tandler-Schneider,2 Wilma Bilger3 1Centre for Reproductive and Prenatal Medicine, Endocrinology and Osteology, Hamburg, Germany; 2Center for Reproductive Medicine, Fertility Center Berlin, Berlin, Germany; 3Medical Affairs, Fertility, Endocrinology and General Medicine, Merck Serono GmbH, Darmstadt, Germany (an affiliate of Merck KGaA, Darmstadt, Germany) Abstract: This prospective, noninterventional, post-marketing surveillance study evaluated doses of recombinant human follicle-stimulating hormone (r-hFSH) using the redesigned follitropin alfa pen in women who were anovulatory or oligomenorrheic and undergoing ovulation induction (OI) alone or OI with intrauterine insemination. The primary endpoint was the proportion of patients who achieved monofollicular or bifollicular development (defined as one or two follicles 15 mm). Secondary endpoints included characteristics of ovulation stimulation treatment, such as mean total and mean daily r-hFSH doses. Data were analyzed for 3,193 patients from 30 German fertility centers. The proportion of patients with monofollicular or bifollicular development was 71.1% (n=2,270 of a total of 3,193 patients; intent-to-treat population). The mean±standard deviation total and daily doses of r-hFSH were 696.9±542.5 IU and 61.7±29.4 IU, respectively. The three doses prescribed most frequently were: 37.5 IU (n=703 from N=3,189; 22.0%), 50.0 IU (n=1,056 from N=3,189; 33.1%), and 75.0 IU (n=738 from N=3,189; 23.1%) on the first day of stimulation; and 37.5 IU (n=465 from N=3,189; 14.6%), 50.0 IU (n=922 from N=3,189; 28.9%), and 75.0 IU (n=895 from N=3,189; 28.1%) on the last day of stimulation. This noninterventional, post-marketing surveillance study found that monofollicular or bifollicular development was achieved in 71% of patients studied and the small dose increment (12.5 IU) of the redesigned follitropin alfa pen allowed individualized treatment of women undergoing OI. Keywords: ovulation induction, pen device, recombinant human follicle-stimulating hormone, follitropin alfahttp://www.dovepress.com/multicenter-noninterventional-post-marketing-surveillance-study-to-eva-peer-reviewed-article-DHPS
collection DOAJ
language English
format Article
sources DOAJ
author Nawroth F
Tandler-Schneider A
Bilger W
spellingShingle Nawroth F
Tandler-Schneider A
Bilger W
Multicenter, noninterventional, post-marketing surveillance study to evaluate dosing of recombinant human follicle-stimulating hormone using the redesigned follitropin alfa pen in women undergoing ovulation induction
Drug, Healthcare and Patient Safety
author_facet Nawroth F
Tandler-Schneider A
Bilger W
author_sort Nawroth F
title Multicenter, noninterventional, post-marketing surveillance study to evaluate dosing of recombinant human follicle-stimulating hormone using the redesigned follitropin alfa pen in women undergoing ovulation induction
title_short Multicenter, noninterventional, post-marketing surveillance study to evaluate dosing of recombinant human follicle-stimulating hormone using the redesigned follitropin alfa pen in women undergoing ovulation induction
title_full Multicenter, noninterventional, post-marketing surveillance study to evaluate dosing of recombinant human follicle-stimulating hormone using the redesigned follitropin alfa pen in women undergoing ovulation induction
title_fullStr Multicenter, noninterventional, post-marketing surveillance study to evaluate dosing of recombinant human follicle-stimulating hormone using the redesigned follitropin alfa pen in women undergoing ovulation induction
title_full_unstemmed Multicenter, noninterventional, post-marketing surveillance study to evaluate dosing of recombinant human follicle-stimulating hormone using the redesigned follitropin alfa pen in women undergoing ovulation induction
title_sort multicenter, noninterventional, post-marketing surveillance study to evaluate dosing of recombinant human follicle-stimulating hormone using the redesigned follitropin alfa pen in women undergoing ovulation induction
publisher Dove Medical Press
series Drug, Healthcare and Patient Safety
issn 1179-1365
publishDate 2015-04-01
description Frank Nawroth,1 Andreas Tandler-Schneider,2 Wilma Bilger3 1Centre for Reproductive and Prenatal Medicine, Endocrinology and Osteology, Hamburg, Germany; 2Center for Reproductive Medicine, Fertility Center Berlin, Berlin, Germany; 3Medical Affairs, Fertility, Endocrinology and General Medicine, Merck Serono GmbH, Darmstadt, Germany (an affiliate of Merck KGaA, Darmstadt, Germany) Abstract: This prospective, noninterventional, post-marketing surveillance study evaluated doses of recombinant human follicle-stimulating hormone (r-hFSH) using the redesigned follitropin alfa pen in women who were anovulatory or oligomenorrheic and undergoing ovulation induction (OI) alone or OI with intrauterine insemination. The primary endpoint was the proportion of patients who achieved monofollicular or bifollicular development (defined as one or two follicles 15 mm). Secondary endpoints included characteristics of ovulation stimulation treatment, such as mean total and mean daily r-hFSH doses. Data were analyzed for 3,193 patients from 30 German fertility centers. The proportion of patients with monofollicular or bifollicular development was 71.1% (n=2,270 of a total of 3,193 patients; intent-to-treat population). The mean±standard deviation total and daily doses of r-hFSH were 696.9±542.5 IU and 61.7±29.4 IU, respectively. The three doses prescribed most frequently were: 37.5 IU (n=703 from N=3,189; 22.0%), 50.0 IU (n=1,056 from N=3,189; 33.1%), and 75.0 IU (n=738 from N=3,189; 23.1%) on the first day of stimulation; and 37.5 IU (n=465 from N=3,189; 14.6%), 50.0 IU (n=922 from N=3,189; 28.9%), and 75.0 IU (n=895 from N=3,189; 28.1%) on the last day of stimulation. This noninterventional, post-marketing surveillance study found that monofollicular or bifollicular development was achieved in 71% of patients studied and the small dose increment (12.5 IU) of the redesigned follitropin alfa pen allowed individualized treatment of women undergoing OI. Keywords: ovulation induction, pen device, recombinant human follicle-stimulating hormone, follitropin alfa
url http://www.dovepress.com/multicenter-noninterventional-post-marketing-surveillance-study-to-eva-peer-reviewed-article-DHPS
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