Trial reportClinical drug investigation2015
Dose-exposure proportionality of a novel recombinant follicle-stimulating hormone (rFSH), FE 999049, derived from a human cell line, with comparison between Caucasian and Japanese women after subcutaneous administration.
Trial report in Clinical drug investigation, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
9 citing papers in PubMed, 1 synthesis or guideline pooled it, 14 citations in OpenAlex.
- The pregnancy outcomes among women receiving individualized algorithm dosing with follitropin delta: a systematic review of randomized controlled trials.Journal of assisted reproduction and genetics · 2024Pooled it
- Pharmacokinetics and Safety of Follitropin Delta in Gonadotropin Down-Regulated Healthy Chinese Women.Clinical drug investigation · 2023Trial
- Population Pharmacokinetic Modelling of FE 999049, a Recombinant Human Follicle-Stimulating Hormone, in Healthy Women After Single Ascending Doses.Drugs in R&D · 2016Trial
- Efficacy of follitropin delta in potential low responders: a pooled analysis of individual patient data from five randomized controlled trials.Frontiers in endocrinology · 2026Article
- One-year cumulative live birth rate associated with the number of oocytes in ovarian stimulation with follitropin delta: a pooled analysis of four randomized controlled trials.Human reproduction (Oxford, England) · 2025Article
- BEYOND: a randomized controlled trial comparing efficacy and safety of individualized follitropin delta dosing in a GnRH agonist versus antagonist protocol during the first ovarian stimulation cycle.Human reproduction (Oxford, England) · 2024Article
- A Narrative Review Discussing the Efficiency of Personalized Dosing Algorithm of Follitropin Delta for Ovarian Stimulation and the Reproductive and Clinical Outcomes.Diagnostics (Basel, Switzerland) · 2023Review
- Prospective multicenter non-interventional real-world study to assess the patterns of use, effectiveness and safety of follitropin delta in routine clinical practice (the PROFILE study).Frontiers in endocrinology · 2022Observational
- New Human Follitropin Preparations: How Glycan Structural Differences May Affect Biochemical and Biological Function and Clinical Effect.Frontiers in endocrinology · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
objectivesFE 999049 is a novel recombinant follicle-stimulating hormone (rFSH) preparation expressed by a human cell line (PER.C6(®)), in contrast to existing rFSH preparations expressed by Chinese hamster ovary (CHO) cell lines. Since the individual dose of rFSH may be altered depending on the response in women undergoing assisted reproductive technologies, knowledge on the dose-exposure linearity and proportionality is important. The purpose of these studies was to investigate the dose-exposure linearity and proportionality properties of FE 999049 with a comparison between Caucasian and Japanese women. This is the first study in Japanese women regarding pharmacokinetics of rFSH.
methodsForty-eight Caucasian and 31 Japanese healthy women of reproductive age were pituitary down-regulated to suppress endogenous FSH. Following single subcutaneous administration of 37.5, 75, 150, 225, or 450 IU (Steelman-Pohley assay), the serum FSH concentration was followed over 10 days.
resultsThe dose-dependent pharmacokinetic parameters of FE 999049, area under the serum concentration-time curve (AUC) and maximum serum concentration (C max), showed dose-exposure linearity and proportionality over 150-450 IU in Caucasian women, the dose interval available for analysis, and 75-450 IU in Japanese women, which was the dose interval investigated. Comparison between Caucasian and Japanese women showed no differences between the populations. The dose-independent parameters were similar over all doses in both populations. FE 999049 was safe and well tolerated at all doses in both populations with few, mostly mild, adverse events.
conclusionThe results demonstrate dose-exposure proportionality and a predictable dose-dependent exposure of FE 999049, with no differences in Caucasian and Japanese women of reproductive age.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.