- EG Cash
- 7,392
Understanding testosterone???
Men on testosterone replacement should take 160 mg of Saw Palmetto with Pygeum twice daily. This herb will block the conversion of testosterone to dihydrotestosterone (DHT) which affects prostate hypertrophy and possibly cancer development. There were no significant side-effects to this herb. In higher dosages, it is registered as Proscar
Until recently, few men in the United States elected testosterone replacement because of the fear of prostate cancer. In Europe, testosterone replacement is much more common. Recent studies imply that U.S. men are misinformed. Rather, the medical literature documents that low levels of testosterone are directly correlated to:
heart disease and myocardial infarction
strokes and cardiovascular disease
prostate cancer (yes, low levels are higher risk)
senile dementia
osteoporosis and hip fracture
Total testosterone is not as important as the Free or unbound testosterone, as the latter is bio-available to the tissue. High levels of estrogen and sex hormone binding globulin reduce bio-available testosterone. Medical publications show that gels and patches raise sex hormone binding globulin. High levels of testosterone from an intramuscular injection raises the estradiol level. That is why low-level, even release pellets are the best modality available today for the man who needs testosterone replacement.
A new philosophy directs the replacement of testosterone in men. Higher testosterone levels have systemic effects, not only improved sexual performance, but also, decreased stress, stronger muscles and possibly less heart, bone, and blood vessel disease.
Early morning testosterone levels in young male individuals are, on average, 50% higher than p.m. levels. Our reference ranges have been derived from a.m. specimens.
Testosterone levels can fluctuate substantially between different days, and sometimes even more rapidly. Assessment of androgen status should be based on more than a single measurement.
The low end of the normal reference range for total testosterone in prepubertal subjects is not yet established.
While free testosterone can be used for the same indications as bioavailable testosterone, determination of bioavailable testosterone levels may be superior to free testosterone measurement in most situations.
THIS IS VERY IMPORTANT TO TAKE INTO CONSIDERATION WHEN TESTING POTENCY OF A LABS GEAR.......
Testosterone Testing Protocol
Effective Date: June 1, 2011
Scope
This protocol reviews serum testosterone testing in adult males and females (aged ≥ 19).
Diagnosis/Investigation
General screening for testosterone deficiency (hypoandrogenism) in men is not recommended but should be guided by
medical history and clinical examination.
Erectile dysfunction by itself is not an indication for testosterone testing. Jack and Zeitlin
1
report “The overall prevalence of
clinically relevant hypogonadism in patients with erectile dysfunction is very low, probably less than 5%, and closer to 1%
to 2%.”In the presence of erectile dysfunction with decreased libido and/or testicular atrophy, serum testosterone testing
is indicated.
1
Testosterone testing is not indicated for the investigation of hypoandrogenism in women, including low libido in women.
Normal ranges for serum total testosterone and calculated bioavailable testosterone (cBAT) show method and age
dependence and are determined by each laboratory independently.
Testosterone Deficiency in Males
a) Signs and Symptoms
In the presence of a clinical indication, serum testosterone measurement is appropriate. Hypoandrogenism is
suggested by the following symptoms and signs.
Table 1: Signs of Hypoandrogenism in Males
• Incomplete or delayed sexual development, eunuchoidism.
• Reduced sexual desire (libido) and activity.
• Decreased spontaneous erections.
• Breast discomfort, gynecomastia.
• Loss of body (axillary and pubic) hair, reduced shaving.
• Very small (especially < 5 ml) or shrinking testes.
• Inability to father children, low or zero sperm count.
• Height loss, fragility fracture, low bone mineral density.
• Hot flushes, sweats.
b) Testing
Specimens should be collected in the early morning
3
(preferably before 10 am). Testing of serum total testosterone
should be done when patients are clinically stable; avoid testing during acute or subacute illness.
Serum total testosterone is the initial test of choice. If the level is below the lower limit of normal
(approximately 10 nmol/L),
2
and a diagnostic question remains, cBAT can be used to confirm hypoandrogenism.
c) Diagnosis
The diagnosis of hypoandrogenism is a probabilistic process based on medical history and physical findings,
followed by investigational tests, guided by the clinical findings. Further investigation to determine the etiology of
hypoandrogenism in men is beyond the scope of this protocol.
d) Monitoring of Treatment
The monitoring of testosterone therapy in men is primarily clinical. The usefulness of serum testosterone testing
while on treatment is controversial.
2
Testosterone Excess in Females
a) Signs and Symptoms
A range of symptoms and signs from hypertrichosis, hirsuitism, to virilization may occur.
b) Testing
Serum total testosterone is frequently normal in women with mild clinical hyperandrogenism (due to androgen
suppression of sex hormone binding globulin (SHBG) production); cBAT testing has a better diagnostic yield for
testosterone excess in women.
4
Repeat serum testosterone testing is not indicated if cBAT is normal. A serum total
testosterone level of less than 7 nmol/L will rule out almost all of the testosterone-secreting neoplasms.
5
Other hormonal testing is dependent on clinical findings and is beyond the scope of this protocol.
c) Diagnosis
The diagnosis of testosterone excess is based on medical history and physical findings, followed by
investigational tests. Virilization that appears over a short period of time should arouse suspicion of adrenal or ovarian
tumors and urgent specialist referral is advised. Further investigation to determine the etiology of androgen excess in
females is beyond the scope of this protocol.
d) Monitoring of Treatment
Response to treatment of hyperandrogenism in women is clinical. Therefore, testing of serum total testosterone and
cBAT in patients treated for hyperandrogenism is not recommended.
Rationale
In men 40 years and over, the symptoms that suggest hypoandrogenism are relatively nonspecific and potentially
attributable to a host of other conditions, including aging itself.
6
Late-onset hypoandrogenism can be defined by the
presence of at least three sexual symptoms (decreased frequency of morning erection, decreased frequency of sexual
thoughts, and erectile dysfunction) associated with low total testosterone and/or a low cBAT.
7
The documentation of low
total testosterone levels in symptomatic elderly men does not invariably imply that a low total testosterone level is the only
or foremost cause of their symptoms. A comprehensive general assessment is required to exclude potential alternative
explanations.
7
Currently, there is no defined syndrome of hypoandrogenism in women. Testosterone testing methods that are
currently available have inadequate analytical performance to diagnose hypoandrogenism in females; therefore, serum
testosterone should not be measured for this purpose.
Circulating total testosterone exists in three forms: free or unbound, weakly bound to albumin, and strongly bound to
SHBG. Serum total testosterone measures all three forms. Analog methods of free testosterone measurement are
inaccurate and are not recommended.
2
Bioavailable testosterone measures free testosterone and albumin bound
testosterone. cBAT is an estimate of the bioavailable testosterone calculated from the total testosterone, SHBG and
albumin concentrations, and their association constants.
Serum testosterone levels can vary significantly for the following reasons:
• age (decline in serum testosterone levels with aging in men is 1% to 2% per year)
• circadian rhythms (peak levels between 8 am and 11 am)
• episodic secretion: 30% of men with mildly hypogonadal serum testosterone levels will have a normal level
on retesting
• exercise - excessive exercise reduces serum testosterone
• comorbid illness with changes in SHBG concentrations (see Table 2)
• illness acuity (avoid diagnosis of hypoandrogenism when patient is ill)
• eating disorders
• medications (see Tables 3 and 4)
• laboratory variations in testosterone testing (lack of a gold standard)
Table 2: Conditions Associated with Alterations in SHBG Concentrations
Decreased SHBG
• Diabetes mellitus
• Moderate obesity
• Nephrotic syndrome
• Use of glucocorticoids, progestins, and androgenic steroids
• Hypothyroidism
• Acromegaly
• Hyperthyroidism
SHBG concentrations
• Aging
• Hepatic cirrhosis and hepatitis
• Use of anticonvulsants
• Use of estrogens
• HIV infection
• Hyperthyroidism
Table 3*: Medications Which May Alter Testosterone Levels in Males
8,9,10
Increase serum testosterone levels Decrease serum testosterone levels
• bicalutamide
• cimetidine
• finasteride
• leuprolide
• phenytoin
• rifampin
• tamoxifen
• valproic acid
Decrease serum testosterone levels
• anabolic steroids
• carbamazepine
• corticosteroids
• cyclophosphamide
• cyproterone
• digoxin
• estrogens
• finasteride
• goserelin
• ketoconazole
• leuprolide
• nilutamide
• opioids
• spironolactone
• tetracycline
• thioridazine
• verapamil
Table 4*: Medications Which May Increase Testosterone Levels in Females
8,9,10
• barbiturates
• clomiphene
• estrogens
• valproic acid
List of Abbreviations
cBAT – calculated bioavailable testosterone
SHBG – sex hormone binding globulin
References
1. Jack G, Zeitlin S. The role of routine serum testosterone testing:
Routine hormone analysis is not indicated as an initial screening test
in the evaluation of erectile dysfunction. Rev Urol. 2004;6(4):203-206.
2. Bhasin S, Cunningham GR, Hayes FJ, et al. Testosterone therapy
in adult men with androgen deficiency syndromes: An Endocrine
Society clinical practice guideline. J Clin Endocrinol Metab.
2010;95(6):2536-2559.
3. Burtis CA, Ashwood ER, Bruns DE, editors. Tietz textbook of clinical
chemistry and molecular diagnostics. 4th ed. St. Louis, MO: Elsevier
Saunders; 2006. p. 2128.
4. Kronenberg HM, Melmed S, Polonsky KS, et al. Williams textbook
of endocrinology. 11th ed. Philadelphia. Saunders, an imprint of
Elsevier Inc. 2008. p. 574.
5. DeCherney AH, Nathan L, Laufer N, et al. Current diagnosis &
treatment obstetrics & gynecology. 10th ed. New York: McGraw-Hill
Companies Inc.; 2007.
6. T’Sjoen G, Feyen E, De Kuyper P, et al. Self-referred patients in an
aging male clinic: much more than androgen deficiency alone. Aging
Male. 2003;6:157-165.
7. Wu FCW, Tajar A, Beynon JM, et al. Identification of late-onset
hypogonadism in middle-aged and elderly men. N Engl J Med.
2010;363(2):123-135.
8. Wilson, DD. McGraw-Hill’s manual of laboratory & diagnostic tests.
New York: McGraw-Hill Professional; 2008. p. 535-536.
9. Young DS. Effects of drugs on clinical laboratory tests. 5th ed.
Washington: American Association for Clinical Chemistry; 1990. p.
(3)737-(3)742.
10. A complete list of references is available by contacting
hlth.guidelines@gov.bc.ca
This guideline is based on scientific evidence current as of the Effective Date.
This guideline was developed by the Guidelines and Protocols Advisory Committee, approved by the British Columbia
Medical Association and adopted by the Medical Services Commission.
DISCLAIMER
The Clinical Practice Guidelines (the “Guidelines”) have been developed by the Guidelines and Protocols Advisory Committee on behalf of the Medical
Services Commission. The Guidelines are intended to give an understanding of a clinical problem, and outline one or more preferred approaches to the
investigation and management of the problem. The Guidelines are not intended as a substitute for the advice or professional judgment of a health care
professional, nor are they intended to be the only approach to the management of clinical problems.
A mobile version of this and other guidelines is also available at www.BCGuidelines.
Men on testosterone replacement should take 160 mg of Saw Palmetto with Pygeum twice daily. This herb will block the conversion of testosterone to dihydrotestosterone (DHT) which affects prostate hypertrophy and possibly cancer development. There were no significant side-effects to this herb. In higher dosages, it is registered as Proscar
Until recently, few men in the United States elected testosterone replacement because of the fear of prostate cancer. In Europe, testosterone replacement is much more common. Recent studies imply that U.S. men are misinformed. Rather, the medical literature documents that low levels of testosterone are directly correlated to:
heart disease and myocardial infarction
strokes and cardiovascular disease
prostate cancer (yes, low levels are higher risk)
senile dementia
osteoporosis and hip fracture
Total testosterone is not as important as the Free or unbound testosterone, as the latter is bio-available to the tissue. High levels of estrogen and sex hormone binding globulin reduce bio-available testosterone. Medical publications show that gels and patches raise sex hormone binding globulin. High levels of testosterone from an intramuscular injection raises the estradiol level. That is why low-level, even release pellets are the best modality available today for the man who needs testosterone replacement.
A new philosophy directs the replacement of testosterone in men. Higher testosterone levels have systemic effects, not only improved sexual performance, but also, decreased stress, stronger muscles and possibly less heart, bone, and blood vessel disease.
Early morning testosterone levels in young male individuals are, on average, 50% higher than p.m. levels. Our reference ranges have been derived from a.m. specimens.
Testosterone levels can fluctuate substantially between different days, and sometimes even more rapidly. Assessment of androgen status should be based on more than a single measurement.
The low end of the normal reference range for total testosterone in prepubertal subjects is not yet established.
While free testosterone can be used for the same indications as bioavailable testosterone, determination of bioavailable testosterone levels may be superior to free testosterone measurement in most situations.
THIS IS VERY IMPORTANT TO TAKE INTO CONSIDERATION WHEN TESTING POTENCY OF A LABS GEAR.......
Testosterone Testing Protocol
Effective Date: June 1, 2011
Scope
This protocol reviews serum testosterone testing in adult males and females (aged ≥ 19).
Diagnosis/Investigation
General screening for testosterone deficiency (hypoandrogenism) in men is not recommended but should be guided by
medical history and clinical examination.
Erectile dysfunction by itself is not an indication for testosterone testing. Jack and Zeitlin
1
report “The overall prevalence of
clinically relevant hypogonadism in patients with erectile dysfunction is very low, probably less than 5%, and closer to 1%
to 2%.”In the presence of erectile dysfunction with decreased libido and/or testicular atrophy, serum testosterone testing
is indicated.
1
Testosterone testing is not indicated for the investigation of hypoandrogenism in women, including low libido in women.
Normal ranges for serum total testosterone and calculated bioavailable testosterone (cBAT) show method and age
dependence and are determined by each laboratory independently.
Testosterone Deficiency in Males
a) Signs and Symptoms
In the presence of a clinical indication, serum testosterone measurement is appropriate. Hypoandrogenism is
suggested by the following symptoms and signs.
Table 1: Signs of Hypoandrogenism in Males
• Incomplete or delayed sexual development, eunuchoidism.
• Reduced sexual desire (libido) and activity.
• Decreased spontaneous erections.
• Breast discomfort, gynecomastia.
• Loss of body (axillary and pubic) hair, reduced shaving.
• Very small (especially < 5 ml) or shrinking testes.
• Inability to father children, low or zero sperm count.
• Height loss, fragility fracture, low bone mineral density.
• Hot flushes, sweats.
b) Testing
Specimens should be collected in the early morning
3
(preferably before 10 am). Testing of serum total testosterone
should be done when patients are clinically stable; avoid testing during acute or subacute illness.
Serum total testosterone is the initial test of choice. If the level is below the lower limit of normal
(approximately 10 nmol/L),
2
and a diagnostic question remains, cBAT can be used to confirm hypoandrogenism.
c) Diagnosis
The diagnosis of hypoandrogenism is a probabilistic process based on medical history and physical findings,
followed by investigational tests, guided by the clinical findings. Further investigation to determine the etiology of
hypoandrogenism in men is beyond the scope of this protocol.
d) Monitoring of Treatment
The monitoring of testosterone therapy in men is primarily clinical. The usefulness of serum testosterone testing
while on treatment is controversial.
2
Testosterone Excess in Females
a) Signs and Symptoms
A range of symptoms and signs from hypertrichosis, hirsuitism, to virilization may occur.
b) Testing
Serum total testosterone is frequently normal in women with mild clinical hyperandrogenism (due to androgen
suppression of sex hormone binding globulin (SHBG) production); cBAT testing has a better diagnostic yield for
testosterone excess in women.
4
Repeat serum testosterone testing is not indicated if cBAT is normal. A serum total
testosterone level of less than 7 nmol/L will rule out almost all of the testosterone-secreting neoplasms.
5
Other hormonal testing is dependent on clinical findings and is beyond the scope of this protocol.
c) Diagnosis
The diagnosis of testosterone excess is based on medical history and physical findings, followed by
investigational tests. Virilization that appears over a short period of time should arouse suspicion of adrenal or ovarian
tumors and urgent specialist referral is advised. Further investigation to determine the etiology of androgen excess in
females is beyond the scope of this protocol.
d) Monitoring of Treatment
Response to treatment of hyperandrogenism in women is clinical. Therefore, testing of serum total testosterone and
cBAT in patients treated for hyperandrogenism is not recommended.
Rationale
In men 40 years and over, the symptoms that suggest hypoandrogenism are relatively nonspecific and potentially
attributable to a host of other conditions, including aging itself.
6
Late-onset hypoandrogenism can be defined by the
presence of at least three sexual symptoms (decreased frequency of morning erection, decreased frequency of sexual
thoughts, and erectile dysfunction) associated with low total testosterone and/or a low cBAT.
7
The documentation of low
total testosterone levels in symptomatic elderly men does not invariably imply that a low total testosterone level is the only
or foremost cause of their symptoms. A comprehensive general assessment is required to exclude potential alternative
explanations.
7
Currently, there is no defined syndrome of hypoandrogenism in women. Testosterone testing methods that are
currently available have inadequate analytical performance to diagnose hypoandrogenism in females; therefore, serum
testosterone should not be measured for this purpose.
Circulating total testosterone exists in three forms: free or unbound, weakly bound to albumin, and strongly bound to
SHBG. Serum total testosterone measures all three forms. Analog methods of free testosterone measurement are
inaccurate and are not recommended.
2
Bioavailable testosterone measures free testosterone and albumin bound
testosterone. cBAT is an estimate of the bioavailable testosterone calculated from the total testosterone, SHBG and
albumin concentrations, and their association constants.
Serum testosterone levels can vary significantly for the following reasons:
• age (decline in serum testosterone levels with aging in men is 1% to 2% per year)
• circadian rhythms (peak levels between 8 am and 11 am)
• episodic secretion: 30% of men with mildly hypogonadal serum testosterone levels will have a normal level
on retesting
• exercise - excessive exercise reduces serum testosterone
• comorbid illness with changes in SHBG concentrations (see Table 2)
• illness acuity (avoid diagnosis of hypoandrogenism when patient is ill)
• eating disorders
• medications (see Tables 3 and 4)
• laboratory variations in testosterone testing (lack of a gold standard)
Table 2: Conditions Associated with Alterations in SHBG Concentrations
Decreased SHBG
• Diabetes mellitus
• Moderate obesity
• Nephrotic syndrome
• Use of glucocorticoids, progestins, and androgenic steroids
• Hypothyroidism
• Acromegaly
• Hyperthyroidism
SHBG concentrations
• Aging
• Hepatic cirrhosis and hepatitis
• Use of anticonvulsants
• Use of estrogens
• HIV infection
• Hyperthyroidism
Table 3*: Medications Which May Alter Testosterone Levels in Males
8,9,10
Increase serum testosterone levels Decrease serum testosterone levels
• bicalutamide
• cimetidine
• finasteride
• leuprolide
• phenytoin
• rifampin
• tamoxifen
• valproic acid
Decrease serum testosterone levels
• anabolic steroids
• carbamazepine
• corticosteroids
• cyclophosphamide
• cyproterone
• digoxin
• estrogens
• finasteride
• goserelin
• ketoconazole
• leuprolide
• nilutamide
• opioids
• spironolactone
• tetracycline
• thioridazine
• verapamil
Table 4*: Medications Which May Increase Testosterone Levels in Females
8,9,10
• barbiturates
• clomiphene
• estrogens
• valproic acid
List of Abbreviations
cBAT – calculated bioavailable testosterone
SHBG – sex hormone binding globulin
References
1. Jack G, Zeitlin S. The role of routine serum testosterone testing:
Routine hormone analysis is not indicated as an initial screening test
in the evaluation of erectile dysfunction. Rev Urol. 2004;6(4):203-206.
2. Bhasin S, Cunningham GR, Hayes FJ, et al. Testosterone therapy
in adult men with androgen deficiency syndromes: An Endocrine
Society clinical practice guideline. J Clin Endocrinol Metab.
2010;95(6):2536-2559.
3. Burtis CA, Ashwood ER, Bruns DE, editors. Tietz textbook of clinical
chemistry and molecular diagnostics. 4th ed. St. Louis, MO: Elsevier
Saunders; 2006. p. 2128.
4. Kronenberg HM, Melmed S, Polonsky KS, et al. Williams textbook
of endocrinology. 11th ed. Philadelphia. Saunders, an imprint of
Elsevier Inc. 2008. p. 574.
5. DeCherney AH, Nathan L, Laufer N, et al. Current diagnosis &
treatment obstetrics & gynecology. 10th ed. New York: McGraw-Hill
Companies Inc.; 2007.
6. T’Sjoen G, Feyen E, De Kuyper P, et al. Self-referred patients in an
aging male clinic: much more than androgen deficiency alone. Aging
Male. 2003;6:157-165.
7. Wu FCW, Tajar A, Beynon JM, et al. Identification of late-onset
hypogonadism in middle-aged and elderly men. N Engl J Med.
2010;363(2):123-135.
8. Wilson, DD. McGraw-Hill’s manual of laboratory & diagnostic tests.
New York: McGraw-Hill Professional; 2008. p. 535-536.
9. Young DS. Effects of drugs on clinical laboratory tests. 5th ed.
Washington: American Association for Clinical Chemistry; 1990. p.
(3)737-(3)742.
10. A complete list of references is available by contacting
hlth.guidelines@gov.bc.ca
This guideline is based on scientific evidence current as of the Effective Date.
This guideline was developed by the Guidelines and Protocols Advisory Committee, approved by the British Columbia
Medical Association and adopted by the Medical Services Commission.
DISCLAIMER
The Clinical Practice Guidelines (the “Guidelines”) have been developed by the Guidelines and Protocols Advisory Committee on behalf of the Medical
Services Commission. The Guidelines are intended to give an understanding of a clinical problem, and outline one or more preferred approaches to the
investigation and management of the problem. The Guidelines are not intended as a substitute for the advice or professional judgment of a health care
professional, nor are they intended to be the only approach to the management of clinical problems.
A mobile version of this and other guidelines is also available at www.BCGuidelines.
