TY - JOUR
T1 - Fundamental Concepts Regarding Testosterone Deficiency and Treatment
T2 - International Expert Consensus Resolutions
AU - Morgentaler, Abraham
AU - Zitzmann, Michael
AU - Traish, Abdulmaged M.
AU - Fox, Anthony W.
AU - Jones, T. Hugh
AU - Maggi, Mario
AU - Arver, Stefan
AU - Aversa, Antonio
AU - Chan, Juliana C.N.
AU - Dobs, Adrian S.
AU - Hackett, Geoffrey I.
AU - Hellstrom, Wayne J.
AU - Lim, Peter
AU - Lunenfeld, Bruno
AU - Mskhalaya, George
AU - Schulman, Claude C.
AU - Torres, Luiz O.
N1 - Funding Information:
Potential Competing Interests: Dr Morgentaler was a paid consultant for AbbVie, Auxilium, Antares, Clarus, Endo, and TesoRx, received honoraria from Bayer, Merck, and Pfizer, and received research grants from Eli Lilly. Dr Jones was a paid consultant for Bayer, Eli Lilly, Merck, and Mereo BioPharma, received honoraria from Bayer, Besins, Clarus, Merck, ProStrakan, and Eli Lilly, and received research grants from Bayer, Besins, ProStrakan. Dr Maggi was a paid consultant for Intercept, Menarini, and ProStrakan, received honoraria from Bayer, and received research grant from Intercept. Dr Aversa received honoraria from Bayer, Eli Lilly, and Menarini. Dr Dobs is on the speaker's bureau for AbbVie, was a paid consultant for AbbVie and Advance Medical, and received research grants from Covance, Clarus, and the National Institutes of Health. Dr Hellstrom was a paid consultant for AbbVie, Allergan, American Medical Systems, Astellas, Coloplast, Endo, Lipocine, Pfizer, and Repros, received research grants from Coloplast, Endo, New England Research Institutes, received honoraria from Endo, and Menarini, and was a board member, officer, and trustee for Theralogix, and served on the data monitoring committee for the NIH-funded Testosterone Trials. Dr Lim was a paid consultant for Bayer and Besins. Dr Mskhalaya was a paid consultant and received honoraria from Bayer and Besins. Dr Torres was a paid consultant for Pfizer, Besins, and Eli Lilly, and received honoraria from Pfizer, Lilly, Bayer, Besins, GSK, and Astellas. Dr Chan has been a paid consultant for Bayer, Pfizer and Besins Healthcare; has received research grants from Bayer and Pfizer (to the Chinese University of Hong Kong), received honoraria from Bayer, Pfizer and Besins Healthcare (donated to the Chinese University of Hong Kong), and is on the speaker bureau for Bayer, Pfizer and Besins. She does not own any stocks in these companies. Dr Arver was a paid consultant for Pfizer, and received honoraria from Bayer and Eli Lilly. Diagnosis and treatment guidelines Consensus Recommendations
Publisher Copyright:
© 2016 Mayo Foundation for Medical Education and Research
PY - 2016/7/1
Y1 - 2016/7/1
N2 - To address widespread concerns regarding the medical condition of testosterone (T) deficiency (TD) (male hypogonadism) and its treatment with T therapy, an international expert consensus conference was convened in Prague, Czech Republic, on October 1, 2015. Experts included a broad range of medical specialties including urology, endocrinology, diabetology, internal medicine, and basic science research. A representative from the European Medicines Agency participated in a nonvoting capacity. Nine resolutions were debated, with unanimous approval: (1) TD is a well-established, clinically significant medical condition that negatively affects male sexuality, reproduction, general health, and quality of life; (2) symptoms and signs of TD occur as a result of low levels of T and may benefit from treatment regardless of whether there is an identified underlying etiology; (3) TD is a global public health concern; (4) T therapy for men with TD is effective, rational, and evidence based; (5) there is no T concentration threshold that reliably distinguishes those who will respond to treatment from those who will not; (6) there is no scientific basis for any age-specific recommendations against the use of T therapy in men; (7) the evidence does not support increased risks of cardiovascular events with T therapy; (8) the evidence does not support increased risk of prostate cancer with T therapy; and (9) the evidence supports a major research initiative to explore possible benefits of T therapy for cardiometabolic disease, including diabetes. These resolutions may be considered points of agreement by a broad range of experts based on the best available scientific evidence.
AB - To address widespread concerns regarding the medical condition of testosterone (T) deficiency (TD) (male hypogonadism) and its treatment with T therapy, an international expert consensus conference was convened in Prague, Czech Republic, on October 1, 2015. Experts included a broad range of medical specialties including urology, endocrinology, diabetology, internal medicine, and basic science research. A representative from the European Medicines Agency participated in a nonvoting capacity. Nine resolutions were debated, with unanimous approval: (1) TD is a well-established, clinically significant medical condition that negatively affects male sexuality, reproduction, general health, and quality of life; (2) symptoms and signs of TD occur as a result of low levels of T and may benefit from treatment regardless of whether there is an identified underlying etiology; (3) TD is a global public health concern; (4) T therapy for men with TD is effective, rational, and evidence based; (5) there is no T concentration threshold that reliably distinguishes those who will respond to treatment from those who will not; (6) there is no scientific basis for any age-specific recommendations against the use of T therapy in men; (7) the evidence does not support increased risks of cardiovascular events with T therapy; (8) the evidence does not support increased risk of prostate cancer with T therapy; and (9) the evidence supports a major research initiative to explore possible benefits of T therapy for cardiometabolic disease, including diabetes. These resolutions may be considered points of agreement by a broad range of experts based on the best available scientific evidence.
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U2 - 10.1016/j.mayocp.2016.04.007
DO - 10.1016/j.mayocp.2016.04.007
M3 - Article
C2 - 27313122
AN - SCOPUS:84986536287
SN - 0025-6196
VL - 91
SP - 881
EP - 896
JO - Mayo Clinic proceedings
JF - Mayo Clinic proceedings
IS - 7
ER -