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Suggested Citation:"Index." Institute of Medicine. 2004. Testosterone and Aging: Clinical Research Directions. Washington, DC: The National Academies Press. doi: 10.17226/10852.
×

Index

A

AACE. See American Association of Clinical Endocrinologists

Absorptiometry, dual-energy X-ray, 48

Acetylcholine, 58

Activities of daily living (ADL), 55

Acute urinary retention (AUR), 139

ADL. See Activities of daily living

Adrenopause, 13

Age, in selected studies of endogenous testosterone levels, 35

Age-related changes

in hormones, 12–14

in testosterone levels, 6, 9, 118

Albumin-bound testosterone, 16–17

Alcohol abuse, exclusion criteria, monitoring, and follow-up of research participants for, 145

Alzheimer’s disease, 132–133

American Association of Clinical Endocrinologists (AACE), 22

American College of Pathologists, 123

American Urological Association (AUA), 141–142

Androgen concentrations, 67, 86, 135

potency of, 15

Androgen-metabolizing enzymes, 87

Androgen receptors (ARs), 58, 86

polymorphisms in, 87–88

Andropause, 13, 22

ARs. See Androgen receptors

AUA. See American Urological Association

AUR. See Acute urinary retention

B

Baltimore Longitudinal Study of Aging (BLSA), 33–34, 76, 142–143, 165

BDI. See Beck Depression Inventory

Beck Depression Inventory (BDI), 62, 66

Benefits, communicating to study participants, 6, 9, 118

Benign prostatic hyperplasia (BPH), 5, 81, 86, 118, 138, 142–143

Bioavailable testosterone (BT), 16, 18

BLSA. See Baltimore Longitudinal Study of Aging

BMD. 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, 48–49

Body mass index (BMI), 39

Suggested Citation:"Index." Institute of Medicine. 2004. Testosterone and Aging: Clinical Research Directions. Washington, DC: The National Academies Press. doi: 10.17226/10852.
×

Bone metabolism and density, 41–47, 136–137

additional studies of testosterone therapy and, 182–183

clinical trials of testosterone therapy and, 43, 45, 46, 47

and endogenous testosterone levels, 43–44

Bone mineral density (BMD), 43, 45, 182–183

BOP. See N-nitrosobis(2-oxypropyl)amine

BPH. See Benign prostatic hyperplasia

Breast Cancer Prevention Trial, 146

Brown-Séquard, Charles, 19

BT. See Bioavailable testosterone

Butenandt, Adolf, 19

C

CAD. See Coronary artery disease

Calcium signaling, 58

Cancer risk factors, as a function of serum prostate specific antigen level and digital rectal examination findings, 140

Carbohydrate metabolism, and cardiovascular risk, 135

Cardiovascular and hematologic outcomes, 73–81

additional studies of testosterone therapy and, 187–189

clinical trials of testosterone therapy and, 79–82

endogenous testosterone levels and, 76, 79

exclusion criteria, monitoring, and follow-up of research participants for, 144–145

Cardiovascular risk factors

and lipid and carbohydrate metabolism, 135

and selected studies of endogenous testosterone levels, 77

Central nervous system function, 67–68

CGI. See Clinical Global Impression score

Changes

in the digital rectal examination, monitoring participants for, 5, 9, 118

in prostate specific antigen levels, monitoring participants for, 5, 9, 118

in testosterone levels, age-related, 6, 9, 118

Cirrhosis, treating with testosterone therapy, 23

Clinical Global Impression score (CGI), 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, 58–59

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), 13

Dehydroepiandrosterone-sulfate (DHEAS), 13, 76, 121

Suggested Citation:"Index." Institute of Medicine. 2004. Testosterone and Aging: Clinical Research Directions. Washington, DC: The National Academies Press. doi: 10.17226/10852.
×

Depression, 61–66, 113

additional studies of testosterone therapy and, 184–185

clinical trials of testosterone therapy and, 63, 64, 66

endogenous testosterone levels and, 62–63

Design issues, 120–125

inclusion criteria, 120–122

measuring testosterone levels, 122–123

sample size, 124–125

testosterone formulation and dose, 123–124

DHEA. See Dehydroepiandrosterone

DHEAS. See Dehydroepiandrosterone-sulfate

DHT. See Dihydrotestosterone

Diabetes

exclusion criteria, monitoring, and follow-up of research participants for, 145

and selected studies of endogenous testosterone levels, 77

See also Insulin sensitivity measures

Digital rectal examination (DRE), 140

monitoring participants for changes in, 5, 9, 118

Dihydrotestosterone (DHT), 15, 20–21, 86–87, 143

Disability outcomes

continuum of diminished, 126

See also Strength, frailty, and disability outcomes

Dose, testosterone, 123–124

DRE. See Digital rectal examination

Drug abuse, exclusion criteria, monitoring, and follow-up of research participants for, 145

Dual-energy X-ray absorptiometry, 48

Dysthmia, measures of, 137

E

E2. See Estradiol

ED. See Erectile dysfunction

Efficacy, defined, 114n

Efficacy and Safety of Testosterone in Elderly Men Trial (ESTEEM), 28, 167

Emphysema, treating with testosterone therapy, 23

Endocrinology, 19

Endogenous testosterone levels, 32

and age, 35

and body composition and strength, 48–49

and bone outcomes, 43, 44

and cardiovascular and hematologic outcomes, 76, 79

and cardiovascular risk factors and diabetes, 77

and cognitive function, 58–59

and mood and depression, 62–63

physiologic regulation of, 6, 9, 118

and prostate outcomes, 89–91

and sexual function, 68–69

Equilibrium dialysis, 18

Erectile dysfunction (ED), 67

ESTEEM. See Efficacy and Safety of Testosterone in Elderly Men Trial

Estradiol (E2) 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), 130

FICSIT. See Frailty and Injuries:

Cooperative Studies of Intervention Techniques

FIM. See Functional Independence Measure

Finasteride, 89

5a-reductase, 20, 87

Follicle stimulating hormone (FSH), 15, 21

Follow-up of research participants, 138–145

for prostate outcomes, 143

Suggested Citation:"Index." Institute of Medicine. 2004. Testosterone and Aging: Clinical Research Directions. Washington, DC: The National Academies Press. doi: 10.17226/10852.
×

Food and Drug Administration (FDA), 19, 160

Formulation, of testosterone, 123–124

Frailty. See Strength, frailty, and disability outcomes

Frailty and Injuries:

Cooperative Studies of Intervention Techniques (FICSIT), 120

Free testosterone (FT), 33, 62

Free testosterone index (FTI), 33

FSFI. See Female Sexual Function Index

FSH. See Follicle stimulating hormone

FT. See Free testosterone

FTI. See Free testosterone index

Functional Independence Measure (FIM), 57

Future research directions, 112–158

additional areas of research, 152

initial efficacy trials in older men, 119–137

protection of research participants, 137–149

strategy for future clinical trials in older men, 113–118

G

GH. See Growth hormone

Ginkgo biloba, 133

Globulin, sex hormone binding, 135

Glucocorticoid therapy, treating pronounced muscle wasting associated with, 22

Gonadotropin-releasing hormone (GnRH), 15, 23, 68

Gonadotropins, 21

Growth, in use of testosterone therapy, 24–27

Growth factor levels, 135

Growth hormone (GH), 13

Gynecomastia, 21

H

Hamilton Depression Rating Scale (Ham-D), 66

HDL. See High-density lipoprotein

Health outcomes, 32–111, 125–137

body composition and strength, 47–54

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), 72–73

additional studies of testosterone therapy and, 186

clinical trials of testosterone therapy and, 73, 74

See also Well-being, quality of life, and vitality

Hematocrit, additional studies reporting, 188–189

Hematologic outcomes

indices of, 135

and randomized placebo-controlled trials of testosterone therapy in older men, 82

Hemochromatosis, 21

Hemostasis, additional studies reporting, 189

Suggested Citation:"Index." Institute of Medicine. 2004. Testosterone and Aging: Clinical Research Directions. Washington, DC: The National Academies Press. doi: 10.17226/10852.
×

Hepatotoxicity, 19

High-density lipoprotein (HDL), 76, 80, 187

HIV. See Human immunodeficiency virus

HRQoL. See Health-related quality of life

Human immunodeficiency virus (HIV), 73, 184, 186

Hypercapnoeic ventilatory drive, 189–190

Hypogonadism, treating with testosterone therapy, 1, 6, 21–22

I

IADL. See Instrumental activities of daily living

IIEF. 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, 123–124

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, 120–125

primary health outcomes, 125–134

secondary health outcomes, 134–137

Institute of Medicine (IOM), 1, 11, 28, 137–138, 147, 165

Instrumental activities of daily living (IADL), 55

Insulin sensitivity measures, in clinical trials of testosterone therapy, 188

Interim monitoring of trial results and stopping rules, 145–146

incorporation into the trial design, 5, 9, 118

International Index of Erectile Functioning (IIEF), 129–130

IOM. See Institute of Medicine

K

Klinefelter’s syndrome, 21

L

LDL. See Low-density lipoprotein

Leydig cell number, 121

LH. See Luteinizing hormone

LHRH. See Luteinizing hormone-releasing hormone

Libido, 17, 21

Lipid metabolism, and cardiovascular risk, 135

Lipid profiles, in clinical trials of testosterone therapy, 80, 187–188

Literature review, 165–167

LNCaP prostate cancer cells, 88

Longitudinal effects of aging, on date-adjusted testosterone and free testosterone index, 37

Low-density lipoprotein (LDL), 187

Luteinizing hormone (LH), 14–15, 21–23, 68, 121

Luteinizing hormone-releasing hormone (LHRH), 128

M

Male breast cancer, exclusion criteria, monitoring, and follow-up of research participants for, 145

Male hair pattern, 17, 21

Male hypogonadism, treating with testosterone therapy, 1, 6, 21–22

Male infertility, 27

Massachusetts Male Aging Study (MMAS), 34, 36, 49, 62, 68, 165

Mechanism of action, of testosterone, 6, 9, 118

Medical conditions treated, 21–23

cirrhosis, 23

emphysema, 23

hypogonadism, 21–22

pronounced muscle wasting associated with glucocorticoid therapy, 22

wasting syndrome of advanced AIDS, 22

Middle-aged men

clinical trials of testosterone therapy in, 161–162

randomized placebo-controlled studies of testosterone therapy in, 174

Suggested Citation:"Index." Institute of Medicine. 2004. Testosterone and Aging: Clinical Research Directions. Washington, DC: The National Academies Press. doi: 10.17226/10852.
×

Mini-Mental State Examination, 132, 134

MMAS. See Massachusetts Male Aging Study

MNU. 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, 62–63

measures of, 137

MRFIT. See Multiple Risk Factor Intervention Trial

Multiple Risk Factor Intervention Trial (MRFIT), 34, 38–39, 79

Muscle mass, maintaining, 17

Muscle wasting associated with glucocorticoid therapy, pronounced, treating with testosterone therapy, 22

Muscle weakness, 113

N

N-methyl-N-nitrosourea (MNU), 86

N-nitrosobis(2-oxypropyl)amine (BOP), 86

National Cancer Institute (NCI), 1, 11, 28, 167

National Heart, Lung, and Blood Institute, 27

National Institute for Nursing Research, 120

National Institute on Aging (NIA), 1, 8, 11, 28, 120, 150, 167

National Institutes of Health (NIH), 1, 11, 27, 120, 167

National Research Council, 148, 165

Public Access Records Office, 168

NCI. See National Cancer Institute

Needle biopsies, 54

NIA. See National Institute on Aging

NIH. See National Institutes of Health

O

Obesity, exclusion criteria, monitoring, and follow-up of research participants for, 145

Occult prostate carcinoma, 139

Older men

need for efficacy studies in, 159–161

randomized placebo-controlled trials of testosterone therapy in, 173–181

recommendations regarding clinical trials of testosterone therapy in, 4, 8–9

Osteopenia, 21, 113

Osteoporosis, 42, 113, 136

P

Partner Encounter Profile, 130

Partner Questionnaire, 130

PCPT. See Prostate Cancer Prevention Trial

Physical function, 54–58

additional studies of testosterone therapy and, 186

clinical trials of testosterone therapy and, 56–58

in community-dwelling American men, 70 years and older, 55

continuum of diminished, 126

See also Strength, frailty, and disability outcomes

Physician’s Health Study, 34, 91

Physiologic regulation, of endogenous testosterone levels, 6, 9, 118

PIN. See Prostate intraepithelial neoplasia

Plasma testosterone. See Testosterone

PLESS. See Proscar Long-term Efficacy and Safety Study

Polycythemia, exclusion criteria, monitoring, and follow-up of research participants for, 144

Potency, 17

Primary health outcomes, 8, 125–134

Proscar Long-term Efficacy and Safety Study (PLESS), 141, 143

Prostate cancer, 86–88, 121, 138

family history of, 139

follow-up, 143

monitoring, 142-–143

occult, 139

Suggested Citation:"Index." Institute of Medicine. 2004. Testosterone and Aging: Clinical Research Directions. Washington, DC: The National Academies Press. doi: 10.17226/10852.
×

Prostate Cancer Prevention Trial (PCPT), 89, 143

Prostate intraepithelial neoplasia (PIN), 86

Prostate outcomes, 81–93

additional studies of testosterone therapy and, 189

clinical trials of testosterone therapy and, 92–94

endogenous testosterone levels and, 89–91

exclusion criteria, monitoring, and follow-up of research participants for, 138–143

Prostate-specific antigen (PSA) levels, 5–6, 9, 92, 140–143, 147, 151

monitoring participants for changes in, 5, 9, 118

thresholds based on age and race, 141

Protection of research participants, 5–6, 9, 137–149

exclusion criteria, monitoring, and follow-up, 138–145

interim monitoring of trial results and stopping rules, 145–146

recommendations, 5–6, 118

risk/benefit communication and consent, 146–149

safety and ethical issues, 138–145

PSA. 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 testosterone therapy in older men, 1, 173–181

and body composition and strength, 50

and bone outcomes, 46

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 short-term 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

Regulation

physiologic, of endogenous testosterone levels, 6, 9, 118

of testosterone and sperm production by LH and FSH, 16

Suggested Citation:"Index." Institute of Medicine. 2004. Testosterone and Aging: Clinical Research Directions. Washington, DC: The National Academies Press. doi: 10.17226/10852.
×

Research issues, 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

Research participants, exclusion criteria, monitoring, and follow-up of, 138–145

Research Triangle Institute (RTI), 166–167

Risks

communicating to study participants, 6, 9, 118, 146–149

See also Cancer risk factors; Cardiovascular risk factors

Rochester Epidemiology Project, 34

RTI. See Research Triangle Institute

Ruzicka, Leopold, 19

S

Safety issues, 138–145

Sample size, 124–125

Sarcopenia, 54, 126

SARMs. See Selective androgen receptor modulators

Secondary health outcomes, 134–137

Selective androgen receptor modulators (SARMs), 7, 20–21, 162

Serotonin, 58

Sertoli cells, 15

Sex hormone-binding globulin (SHBG), 18, 22, 33, 91, 122–123, 135

Sex steroid action, genetic determinants of, 136

Sexual Experience Profile, 130

Sexual function, 3, 66–72, 113, 128–131

additional studies of testosterone therapy and, 185–186

clinical trials of testosterone therapy and, 69, 70, 72

endogenous testosterone levels and, 68–69

SF-36. See Short Form 36 item questionnaire

SHBG. See Sex hormone-binding globulin

Short Form 36 item questionnaire (SF-36), 58, 73, 134

Short-term efficacy trials to determine benefit, 4, 8, 117

coordination of clinical trials, 8

primary outcomes, 8

study population for initial trials, 8

testosterone preparation and dosages, 8

Sleep apnea, 93, 189

exclusion criteria, monitoring, and follow-up of research participants for uncontrolled, 189–190

Somatopause, 13

Spermatogenesis, 15, 17

Starling, Ernest Henry, 19

Strength, frailty, and disability outcomes, 3, 21, 113, 125–128

Study population, for initial trials, 8

T

TC. See Testosterone cypionate

TE. 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), 19

Testosterone levels

age-related changes in, 6, 9, 17, 118

in clinical studies, 198–201

Suggested Citation:"Index." Institute of Medicine. 2004. Testosterone and Aging: Clinical Research Directions. Washington, DC: The National Academies Press. doi: 10.17226/10852.
×

endogenous, physiologic regulation of, 6, 9, 118

measuring, 122–123

Testosterone therapy, 18–24

additional studies of, 182–197

administering, 19

and body composition and strength, 183–184

and bone, 182–183

and cardiovascular and hematologic outcomes, 187–189

categorization of studies on, 166

and cognitive function, 184–185

and health-related quality of life, 186

and mood and depression, 184–185

and physical function, 186

prescription trend, 25

and prostate outcomes, 189

and sexual function, 185–186

treating medical conditions with, 21–23

use in aging men, 23–24

TF. See Total testosterone

Thromboembolic disease, exclusion criteria, monitoring, and follow-up of research participants for, 144–145

Total testosterone (TF), 121

True andropause, 13

U

Uncontrolled sleep apnea, exclusion criteria, monitoring, and follow-up of research participants for, 189–190

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. See Strength, frailty, and disability outcomes

Well-being, quality of life, and vitality, 3, 113, 133–134

WHI. See Women’s Health Initiative

Women’s Health Initiative (WHI), 11, 13, 27, 146, 160

Workshop, 12, 167–172

X

X-ray absorptiometry, dual-energy, 48

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Testosterone and Aging: Clinical Research Directions Get This Book
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Popular culture often equates testosterone with virility, strength, and the macho male physique. Viewed by some as an “antiaging tonic,” testosterone’s reputation and increased use by men of all ages in the United States have outpaced the scientific evidence about its potential benefits and risks. In particular there has been growing concern about an increase in the number of middle-aged and older men using testosterone and the lack of scientific data on the effect it may have on aging males. Studies of testosterone replacement therapy in older men have generally been of short duration, involving small numbers of participants and often lacking adequate controls. Testosterone and Aging weighs the options of future research directions, examines the risks and benefits of testosterone replacement therapy, assesses the potential public health impact of such therapy in the United States, and considers ethical issues related to the conduct of clinical trials. Testosterone therapy remains an attractive option to many men even as speculation abounds regarding its potential.

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