First-in-human trial assessing the pharmacokinetic-pharmacodynamic profile of a novel recombinant human chorionic gonadotropin in healthy women and men of reproductive age
First published: 13 May 2021
https://doi.org/10.1111/cts.13037
Presented at the 35th Annual Meeting of the European Society of Human Reproduction and Embryology, June 23–26, 2019, Vienna, Austria.
Funding information
This trial was funded by Ferring Pharmaceuticals A/S, Copenhagen, Denmark.
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Could not find this on here, so here goes, to my knowledge at least Pregnyl 5000iu is CG alfa, the interesting stuff is here:
Part 3: Single dose PD in men
The mean baseline corrected serum testosterone concentrations after single dosing of CG beta and CG alfa are shown in Figure 3.
[IMG alt="Details are in the caption following the image"]https://ascpt.onlinelibrary.wiley.com/cms/asset/0bdb0775-d532-4cf0-b19e-c5d267c425fe/cts13037-fig-0003-m.png[/IMG]
FIGURE 3
Open in figure viewerPowerPoint
Time course of baseline corrected serum testosterone concentrations after single s.c. administration of CG beta and CG alfa to men in part 3 of the trial. Individual serum concentrations are shown with dots and the arithmetic mean with solid lines. Standard deviation is shown with shaded areas. CG, chorionic gonadotropin
The median time for reaching baseline corrected maximal testosterone concentration was 96 h (range 48–168 h) after a single s.c. injection of 125 µg CG beta and 72 h (range 48–120 h) after a single s.c. injection of 125 µg CG alfa with geometric mean testosterone plasma Cmax concentrations of 7.1 ng/ml (CV%: 30%) and 6.7 ng/ml (CV%: 32%), respectively. In accordance with the concentration profiles and exposure of CG beta and CG alfa, the testosterone AUCt was 1.6–fold (90% CI = 1.50–1.68) greater after administration with CG beta than with CG alfa.