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Pages 211-220

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From page 211... ... See Bone mineral density BMI. See Body mass index Body composition, measures of, 135 Body composition and strength, 47-54 additional studies of testosterone therapy and, 183-184 clinical trials of testosterone therapy and, 49, 50, 52-54 and endogenous testosterone levels, 4849 Body mass index (BMI) Read the entire page →
From page 212... ... , 66 Clinical trials of testosterone therapy and body composition and strength, 49, 52-54 and bone-related outcomes, 43, 45, 47 and cardiovascular and hematologic outcomes, 79-81 and cognitive function, 59-61 coordination of, 8 and health-related quality of life, 73 insulin sensitivity measures, 188 lipid profiles, 80, 187-188 and mood and depression, 63, 66 and physical function, 56-58 and prostate outcomes, 92-93 recommendations, 4, 8-9 red blood cell measures, 80 and sexual function, 69, 72 Clinical trials of testosterone therapy in middle-aged men, 7, 161-162 Clinical trials of testosterone therapy in older men, 2-4, 8, 27-28, 117 if short-term efficacy is established, 4, 9, 117 Cognitive function, 3, 58-61, 113, 131-133 additional studies of testosterone therapy and, 184-185 clinical trials of testosterone therapy and, 59-61 endogenous testosterone levels and, 5859 Concentrations, of estrogen and androgens, 135 Coordination of clinical trials, 8 of initial efficacy trials, 119-120 Coronary artery disease (CAD) , 73, 76, 79 CYP17 polymorphisms, 87 Cytokines, 42 D Data sources and methods, 165-172 committee meetings and workshop, 167-172 literature review, 165-167 Dehydroepiandrosterone (DHEA) Read the entire page →
From page 213... ... concentrations, 14-15, 76, 91 Estrogen concentrations, 121,135 Ethical issues, 138-145 Exclusion criteria for research participants, 138-145 for men at high risk for developing prostate cancer, 5, 9,118 for men at high risk for requiring intervention to treat benign prostatic hyperplasia, 5, 9,118 for prostate outcomes, 139-142 F Family history of prostate cancer, effect on lifetime risk of clinical prostate cancer, 139 Fat distribution, 17 FDA. See Food and Drug Administration Federal Policy for Protection of Human Subjects, 137n Female Sexual Function Index (FSFI) Read the entire page →
From page 214... ... , 66 HDL. See High-density lipoprotein Health outcomes, 32-111,125-137 body composition and strength, 47-54 INDEX bone metabolism and density, 41-47, 136-137 cardiovascular outcomes, 73-81,135 changes in endogenous testosterone levels with aging, 33-39 cognitive function, 58-61,131-133 concentration of estrogen and androgens, 135 effects on sex hormone binding globulin, 135 genetic determinants of sex steroid action, 136 growth factor levels, 135 health-related quality of life, 72-73 hematologic outcomes, 73-81,135 inflammation measures, 135 lipid and carbohydrate metabolism and cardiovascular risk, 135 literature review, 39-41 measures of body composition, 135 measures of dysthmia, 137 mood and depression, 61-66,137 multiple outcomes, 93-99 physical function, 54-58 potentially adverse, exclusion criteria monitoring, and follow-up of research participants for, 144-145 prostate outcomes, 81-93 sexual function, 66-72,128-131 strength, frailty, and disability outcomes, 3, 125-128 well-being, quality of life, and vitality, 3, 133-134 Health-related quality of life (HRQoL) Read the entire page →
From page 215... ... See International Index of Erectile Functioning Implementation issues, 120-125 inclusion criteria, 120-122 measuring testosterone levels, 122-123 sample size, 124-125 testosterone formulation and dose, 123124 Inclusion criteria, 120-122 Inflammation measures, 135 Initial efficacy trials in older men, 119-137 coordination of initial efficacy trials, 119-120 design and implementation issues, 120125 primary health outcomes, 125-134 secondary health outcomes, 134-137 Institute of Medicine (IOM) , 1, 11, 28, 137138, 147, 165 Instrumental activities of daily living (IADL) Read the entire page →
From page 216... ... See N-methyl-N-nitrosourea Monitoring of research participants for adverse effects, 5, 9, 118, 138-145 changes in prostate specific antigen levels, 5, 9, 118 changes in the digital rectal examination, 5, 9, 118 prostate outcomes, 142-143 Mood, 61-66 additional studies of testosterone therapy and, 184-185 clinical trials of testosterone therapy and, 63, 64, 66 endogenous testosterone levels and, 6263 measures of, 137 MRFIT. See Multiple Risk Factor Intervention Trial Multiple Risk Factor Intervention Trial (MRFIT) Read the entire page →
From page 217... ... See Prostate-specific antigen levels Psychiatric illness and aggression, exclusion criteria, monitoring, and follow-up of research participants for serious, 145 Q Quality of life. See Health-related quality of life R Radioimmunoassay, 18 Rancho Bernardo study, 34, 39-40, 43, 58, 79 Randomized placebo-controlled studies of testosterone therapy in middle-aged men, 174 Randomized placebo-controlled trials of Regulation testosterone therapy in older men, 1, 173-181 and body composition and strength, 50 and bone outcomes, 46 217 and cardiovascular or hematologic outcomes, 82 and cognitive function, 60 and mood and depression, 64 and multiple outcome measures, 98 and physical function, 56 and prostate outcomes, 94 and quality of life in, 74 and sexual function, 70 Recommendations for further research, 6, 9, 118 age-related changes in testosterone levels, 6, 9,118 mechanism of action of testosterone, 6, 9, 118 physiologic regulation of endogenous testosterone levels, 6, 9,118 Recommendations for protection of research participants, 5-6,118 communicating risks and benefits to study participants, 6, 9, 118 excluding men at high risk for developing prostate cancer, 5, 9, 118 excluding men at high risk for requiring intervention to treat benign prostatic hyperplasia, 5, 9,118 incorporating interim monitoring findings into the trial design, 5, 9, 118 monitoring participants for any adverse effects, 5, 9,118 planning carefully to address prostate risk issues, 6, 9,118 Recommendations regarding clinical trials of testosterone therapy in older men, 4,8-9,116-118,150 beginning with short-term efficacy trials to determine benefit, 4, 8, 117 conducting longer-term studies if shortterm efficacy is established, 4, 9, 117 Red blood cell measures, 80 additional studies reporting hematocrit, 188-189 additional studies reporting hemostasis, 189 in clinical trials of testosterone therapy, 80 physiologic, of endogenous testosterone levels, 6, 9,118 of testosterone and sperm production by LH and FSH, 16 Read the entire page →
From page 218... ... See Testosterone enanthate Testosterone, 17 albumin-bound, 16-17 bioavailable, 16, 18 formulation and dose, 123-124 and human development, and health, 14-17 mechanism of action of, 6, 9, 118 partitions in the serum, 17 preparation and dosages, 8, 150 synthesis pathways in human testis, 15 using as a therapeutic intervention, not a preventive measure, 115 Testosterone and health outcomes, 32-111 body composition and strength, 47-54 bone, 41-47 cardiovascular and hematologic outcomes, 73-81 changes in endogenous testosterone levels with aging, 33-39 cognitive function, 58-61 health-related quality of life, 72-73 literature review, 39-41 mood and depression, 61-66 multiple outcomes, 93-99 other health outcomes, 93 physical function, 54-58 prostate outcomes, 81-93 sexual function, 66-72 Testosterone cypionate (TC) , 19 Testosterone enanthate (TE) Read the entire page →
From page 219... ... , 121 True andropause, 13 U Uncontrolled sleep apnea, exclusion criteria, monitoring, and follow-up of research participants for, 189-190 219 V Ventilatory drive, hypercapnoeic, 189-190 Vitality. See Well-being, quality of life, and vitality Vitamin D deficiency, 14 W Wasting syndrome of advanced AIDS, treating with testosterone therapy, 22 Weakness. Read the entire page →

From page 211...

... See Bone mineral density BMI. See Body mass index Body composition, measures of, 135 Body composition and strength, 47-54 additional studies of testosterone therapy and, 183-184 clinical trials of testosterone therapy and, 49, 50, 52-54 and endogenous testosterone levels, 4849 Body mass index (BMI)

Read the entire page →

From page 212...

... , 66 Clinical trials of testosterone therapy and body composition and strength, 49, 52-54 and bone-related outcomes, 43, 45, 47 and cardiovascular and hematologic outcomes, 79-81 and cognitive function, 59-61 coordination of, 8 and health-related quality of life, 73 insulin sensitivity measures, 188 lipid profiles, 80, 187-188 and mood and depression, 63, 66 and physical function, 56-58 and prostate outcomes, 92-93 recommendations, 4, 8-9 red blood cell measures, 80 and sexual function, 69, 72 Clinical trials of testosterone therapy in middle-aged men, 7, 161-162 Clinical trials of testosterone therapy in older men, 2-4, 8, 27-28, 117 if short-term efficacy is established, 4, 9, 117 Cognitive function, 3, 58-61, 113, 131-133 additional studies of testosterone therapy and, 184-185 clinical trials of testosterone therapy and, 59-61 endogenous testosterone levels and, 5859 Concentrations, of estrogen and androgens, 135 Coordination of clinical trials, 8 of initial efficacy trials, 119-120 Coronary artery disease (CAD) , 73, 76, 79 CYP17 polymorphisms, 87 Cytokines, 42 D Data sources and methods, 165-172 committee meetings and workshop, 167-172 literature review, 165-167 Dehydroepiandrosterone (DHEA)

Read the entire page →

From page 213...

... concentrations, 14-15, 76, 91 Estrogen concentrations, 121,135 Ethical issues, 138-145 Exclusion criteria for research participants, 138-145 for men at high risk for developing prostate cancer, 5, 9,118 for men at high risk for requiring intervention to treat benign prostatic hyperplasia, 5, 9,118 for prostate outcomes, 139-142 F Family history of prostate cancer, effect on lifetime risk of clinical prostate cancer, 139 Fat distribution, 17 FDA. See Food and Drug Administration Federal Policy for Protection of Human Subjects, 137n Female Sexual Function Index (FSFI)

Read the entire page →

From page 214...

... , 66 HDL. See High-density lipoprotein Health outcomes, 32-111,125-137 body composition and strength, 47-54 INDEX bone metabolism and density, 41-47, 136-137 cardiovascular outcomes, 73-81,135 changes in endogenous testosterone levels with aging, 33-39 cognitive function, 58-61,131-133 concentration of estrogen and androgens, 135 effects on sex hormone binding globulin, 135 genetic determinants of sex steroid action, 136 growth factor levels, 135 health-related quality of life, 72-73 hematologic outcomes, 73-81,135 inflammation measures, 135 lipid and carbohydrate metabolism and cardiovascular risk, 135 literature review, 39-41 measures of body composition, 135 measures of dysthmia, 137 mood and depression, 61-66,137 multiple outcomes, 93-99 physical function, 54-58 potentially adverse, exclusion criteria monitoring, and follow-up of research participants for, 144-145 prostate outcomes, 81-93 sexual function, 66-72,128-131 strength, frailty, and disability outcomes, 3, 125-128 well-being, quality of life, and vitality, 3, 133-134 Health-related quality of life (HRQoL)

Read the entire page →

From page 215...

... See International Index of Erectile Functioning Implementation issues, 120-125 inclusion criteria, 120-122 measuring testosterone levels, 122-123 sample size, 124-125 testosterone formulation and dose, 123124 Inclusion criteria, 120-122 Inflammation measures, 135 Initial efficacy trials in older men, 119-137 coordination of initial efficacy trials, 119-120 design and implementation issues, 120125 primary health outcomes, 125-134 secondary health outcomes, 134-137 Institute of Medicine (IOM) , 1, 11, 28, 137138, 147, 165 Instrumental activities of daily living (IADL)

Read the entire page →

From page 216...

... See N-methyl-N-nitrosourea Monitoring of research participants for adverse effects, 5, 9, 118, 138-145 changes in prostate specific antigen levels, 5, 9, 118 changes in the digital rectal examination, 5, 9, 118 prostate outcomes, 142-143 Mood, 61-66 additional studies of testosterone therapy and, 184-185 clinical trials of testosterone therapy and, 63, 64, 66 endogenous testosterone levels and, 6263 measures of, 137 MRFIT. See Multiple Risk Factor Intervention Trial Multiple Risk Factor Intervention Trial (MRFIT)

Read the entire page →

From page 217...

... See Prostate-specific antigen levels Psychiatric illness and aggression, exclusion criteria, monitoring, and follow-up of research participants for serious, 145 Q Quality of life. See Health-related quality of life R Radioimmunoassay, 18 Rancho Bernardo study, 34, 39-40, 43, 58, 79 Randomized placebo-controlled studies of testosterone therapy in middle-aged men, 174 Randomized placebo-controlled trials of Regulation testosterone therapy in older men, 1, 173-181 and body composition and strength, 50 and bone outcomes, 46 217 and cardiovascular or hematologic outcomes, 82 and cognitive function, 60 and mood and depression, 64 and multiple outcome measures, 98 and physical function, 56 and prostate outcomes, 94 and quality of life in, 74 and sexual function, 70 Recommendations for further research, 6, 9, 118 age-related changes in testosterone levels, 6, 9,118 mechanism of action of testosterone, 6, 9, 118 physiologic regulation of endogenous testosterone levels, 6, 9,118 Recommendations for protection of research participants, 5-6,118 communicating risks and benefits to study participants, 6, 9, 118 excluding men at high risk for developing prostate cancer, 5, 9, 118 excluding men at high risk for requiring intervention to treat benign prostatic hyperplasia, 5, 9,118 incorporating interim monitoring findings into the trial design, 5, 9, 118 monitoring participants for any adverse effects, 5, 9,118 planning carefully to address prostate risk issues, 6, 9,118 Recommendations regarding clinical trials of testosterone therapy in older men, 4,8-9,116-118,150 beginning with short-term efficacy trials to determine benefit, 4, 8, 117 conducting longer-term studies if shortterm efficacy is established, 4, 9, 117 Red blood cell measures, 80 additional studies reporting hematocrit, 188-189 additional studies reporting hemostasis, 189 in clinical trials of testosterone therapy, 80 physiologic, of endogenous testosterone levels, 6, 9,118 of testosterone and sperm production by LH and FSH, 16

Read the entire page →

From page 218...

... See Testosterone enanthate Testosterone, 17 albumin-bound, 16-17 bioavailable, 16, 18 formulation and dose, 123-124 and human development, and health, 14-17 mechanism of action of, 6, 9, 118 partitions in the serum, 17 preparation and dosages, 8, 150 synthesis pathways in human testis, 15 using as a therapeutic intervention, not a preventive measure, 115 Testosterone and health outcomes, 32-111 body composition and strength, 47-54 bone, 41-47 cardiovascular and hematologic outcomes, 73-81 changes in endogenous testosterone levels with aging, 33-39 cognitive function, 58-61 health-related quality of life, 72-73 literature review, 39-41 mood and depression, 61-66 multiple outcomes, 93-99 other health outcomes, 93 physical function, 54-58 prostate outcomes, 81-93 sexual function, 66-72 Testosterone cypionate (TC) , 19 Testosterone enanthate (TE)

Read the entire page →

From page 219...

... , 121 True andropause, 13 U Uncontrolled sleep apnea, exclusion criteria, monitoring, and follow-up of research participants for, 189-190 219 V Ventilatory drive, hypercapnoeic, 189-190 Vitality. See Well-being, quality of life, and vitality Vitamin D deficiency, 14 W Wasting syndrome of advanced AIDS, treating with testosterone therapy, 22 Weakness.

Read the entire page →

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Index Pages 211-220

Index
Pages 211-220