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First-in-human trial assessing the pharmacokinetic-pharmacodynamic profile of a novel recombinant human chorionic gonadotropin in healthy women and men of reproductive age


[URL unfurl="true"]https://ascpt.onlinelibrary.wiley.com/doi/full/10.1111/cts.13037[/URL]

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.


                                                              Details are in the caption following the image                   

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.


[ATTACH=full]26671[/ATTACH]


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