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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.

Nawroth F, Tandler-Schneider A, Bilger W - Drug Healthc Patient Saf (2015)

Bottom Line: 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.

View Article: PubMed Central - PubMed

Affiliation: Centre for Reproductive and Prenatal Medicine, Endocrinology and Osteology, Hamburg, 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.

No MeSH data available.


Related in: MedlinePlus

The proportion of patients who received a dose of 37.5, 50.0, and 75.0 IU on the first day of stimulation (n=2,497) according to whether they received or did not receive a dose adjustment. All doses were prescribed at the physicians’ discretion.Abbreviation: r-hFSH, recombinant human follicle-stimulating hormone.
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f2-dhps-7-063: The proportion of patients who received a dose of 37.5, 50.0, and 75.0 IU on the first day of stimulation (n=2,497) according to whether they received or did not receive a dose adjustment. All doses were prescribed at the physicians’ discretion.Abbreviation: r-hFSH, recombinant human follicle-stimulating hormone.

Mentions: On the first day of stimulation, 12.5 IU (lowest possible dose) was prescribed for 74 of 3,189 (2.3%) patients, and 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%, Figure 1A). On the last day of stimulation, 12.5 IU was prescribed for 52 of 3,189 (1.6%) patients, and the three doses prescribed most frequently were 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%, Figure 1B). Figure 2 shows the proportion of patients who received a 37.5, 50.0, or 75.0 IU dose on the first day of stimulation according to whether they received/did not receive a dose adjustment.


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.

Nawroth F, Tandler-Schneider A, Bilger W - Drug Healthc Patient Saf (2015)

The proportion of patients who received a dose of 37.5, 50.0, and 75.0 IU on the first day of stimulation (n=2,497) according to whether they received or did not receive a dose adjustment. All doses were prescribed at the physicians’ discretion.Abbreviation: r-hFSH, recombinant human follicle-stimulating hormone.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4403741&req=5

f2-dhps-7-063: The proportion of patients who received a dose of 37.5, 50.0, and 75.0 IU on the first day of stimulation (n=2,497) according to whether they received or did not receive a dose adjustment. All doses were prescribed at the physicians’ discretion.Abbreviation: r-hFSH, recombinant human follicle-stimulating hormone.
Mentions: On the first day of stimulation, 12.5 IU (lowest possible dose) was prescribed for 74 of 3,189 (2.3%) patients, and 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%, Figure 1A). On the last day of stimulation, 12.5 IU was prescribed for 52 of 3,189 (1.6%) patients, and the three doses prescribed most frequently were 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%, Figure 1B). Figure 2 shows the proportion of patients who received a 37.5, 50.0, or 75.0 IU dose on the first day of stimulation according to whether they received/did not receive a dose adjustment.

Bottom Line: 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.

View Article: PubMed Central - PubMed

Affiliation: Centre for Reproductive and Prenatal Medicine, Endocrinology and Osteology, Hamburg, 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.

No MeSH data available.


Related in: MedlinePlus