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Importance of measuring testosterone in enzyme-inhibited plasma for oral testosterone undecanoate androgen replacement therapy clinical trials

AIM: Testosterone undecanoate (TU) is metabolized by nonspecific esterases in blood to testosterone (T). Typical clinical practice has been to analyze testosterone in human serum. The degradation of TU to testosterone was evaluated in conditions typically used in clinical studies. METHODS & RESU...

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Autores principales: Lachance, Sylvain, Dhingra, Om, Bernstein, James, Gagnon, Stéphanie, Savard, Caroline, Pelletier, Nathalie, Boudreau, Nadine, Lévesque, Ann
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Future Science Ltd 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5137954/
https://www.ncbi.nlm.nih.gov/pubmed/28031910
http://dx.doi.org/10.4155/fso.15.55
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author Lachance, Sylvain
Dhingra, Om
Bernstein, James
Gagnon, Stéphanie
Savard, Caroline
Pelletier, Nathalie
Boudreau, Nadine
Lévesque, Ann
author_facet Lachance, Sylvain
Dhingra, Om
Bernstein, James
Gagnon, Stéphanie
Savard, Caroline
Pelletier, Nathalie
Boudreau, Nadine
Lévesque, Ann
author_sort Lachance, Sylvain
collection PubMed
description AIM: Testosterone undecanoate (TU) is metabolized by nonspecific esterases in blood to testosterone (T). Typical clinical practice has been to analyze testosterone in human serum. The degradation of TU to testosterone was evaluated in conditions typically used in clinical studies. METHODS & RESULTS: Freshly collected whole blood was fortified with TU at known concentration. Serum was prepared and T concentration was determined by LC–MS/MS. It was observed that TU degrades extensively to T in human blood under conditions typical of harvesting serum causing overestimation of T concentration of up to 243%. These results were confirmed in a clinical study in which serum and plasma samples were compared. CONCLUSION: It was demonstrated that T must be analyzed in enzyme-inhibited plasma when TU is the administered medication.
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spelling pubmed-51379542016-12-28 Importance of measuring testosterone in enzyme-inhibited plasma for oral testosterone undecanoate androgen replacement therapy clinical trials Lachance, Sylvain Dhingra, Om Bernstein, James Gagnon, Stéphanie Savard, Caroline Pelletier, Nathalie Boudreau, Nadine Lévesque, Ann Future Sci OA Research Article AIM: Testosterone undecanoate (TU) is metabolized by nonspecific esterases in blood to testosterone (T). Typical clinical practice has been to analyze testosterone in human serum. The degradation of TU to testosterone was evaluated in conditions typically used in clinical studies. METHODS & RESULTS: Freshly collected whole blood was fortified with TU at known concentration. Serum was prepared and T concentration was determined by LC–MS/MS. It was observed that TU degrades extensively to T in human blood under conditions typical of harvesting serum causing overestimation of T concentration of up to 243%. These results were confirmed in a clinical study in which serum and plasma samples were compared. CONCLUSION: It was demonstrated that T must be analyzed in enzyme-inhibited plasma when TU is the administered medication. Future Science Ltd 2015-11-01 /pmc/articles/PMC5137954/ /pubmed/28031910 http://dx.doi.org/10.4155/fso.15.55 Text en © inVentiv Health clinical This work is licensed under a Creative Commons Attribution 4.0 License (http://creativecommons.org/licenses/by/4.0/)
spellingShingle Research Article
Lachance, Sylvain
Dhingra, Om
Bernstein, James
Gagnon, Stéphanie
Savard, Caroline
Pelletier, Nathalie
Boudreau, Nadine
Lévesque, Ann
Importance of measuring testosterone in enzyme-inhibited plasma for oral testosterone undecanoate androgen replacement therapy clinical trials
title Importance of measuring testosterone in enzyme-inhibited plasma for oral testosterone undecanoate androgen replacement therapy clinical trials
title_full Importance of measuring testosterone in enzyme-inhibited plasma for oral testosterone undecanoate androgen replacement therapy clinical trials
title_fullStr Importance of measuring testosterone in enzyme-inhibited plasma for oral testosterone undecanoate androgen replacement therapy clinical trials
title_full_unstemmed Importance of measuring testosterone in enzyme-inhibited plasma for oral testosterone undecanoate androgen replacement therapy clinical trials
title_short Importance of measuring testosterone in enzyme-inhibited plasma for oral testosterone undecanoate androgen replacement therapy clinical trials
title_sort importance of measuring testosterone in enzyme-inhibited plasma for oral testosterone undecanoate androgen replacement therapy clinical trials
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5137954/
https://www.ncbi.nlm.nih.gov/pubmed/28031910
http://dx.doi.org/10.4155/fso.15.55
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