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In the 7/1/02 edition of OB/GYN News there is a study on female "androgen insufficiency". The even better news is that this article does not give specific diagnostic criteria (other than "low" testosterone levels- in the lower 25th percentile) nor recommendations for treatments.
What it does do is to lay down the groundwork for "studies" or "experimental therapies" for women who meet these vague criteria, thereby giving Ob/Gyn's a whole lot more leeway in
prescribing androgenic meds and drawing labs.
--------------------------------------------------------------------------------
Provides management algorithm
New Statement Defines Androgen Insufficiency
Betsy Bates
Los Angeles Bureau
LOS ANGELES — A newly published consensus statement on female androgen insufficiency offers a working definition of the condition and an algorithm for its management.
It also emphasizes an urgent need for development of a practical, affordable assay for assessment of bioavailable testosterone in women. “Current androgen assays are unsatisfactory primarily because of their lack of [either] sensitivity or reliability at the lower ranges of normal,” the document states (Fertil. Steril. 77[4]:660-65, 2002).
Dr. Irwin Goldstein, director of the Center for Sexual Medicine and professor of urology at Boston University, hailed the new guidelines as a “bible,” offering perspective on a topic that has long been underappreciated. His remarks came during a session on female sexuality at the annual meeting of the American College of Obstetricians and Gynecologists.
The panel that wrote the statement consisted of experts in the field from throughout the United States and Australia.
Panelist Dr. Goldstein said that the document may specifically spur interest among ob.gyns. in treating the 60 million women in America who have sexual dysfunction. To date, less than 5% of ob.gyns. have indicated an enthusiasm to get involved in the field, perhaps because it has been marked by a lack of good research to guide their practice.
“Historically, androgens have been identified with masculinity or male sexual function, which has undoubtedly contributed to a lack of recognition of androgen effects in women,” according to the consensus statement, which was written by 19 panelists who attended a conference in June 2001 at the Robert Wood Johnson Medical School in Piscataway, N.J.
“In fact,” the statement continued, “androgens are necessary not only for the development of reproductive function and hormonal homeostasis in women, but they also represent the immediate precursors for the biosynthesis of estrogen. Androgens affect sexual desire, bone density, muscle mass and strength, adipose tissue distribution, mood, energy, and psychological well-being.”
To help guide clinicians, the panel defined androgen insufficiency in women as a pattern of clinical symptoms in the presence of decreased bioavailable testosterone and normal estrogen status.
Symptoms must be present for a diagnosis to be made and can include a diminished sense of well-being or dysphoric mood; persistent, unexplained fatigue; and sexual function changes, including decreases in libido, sexual receptivity, and pleasure. Other potential symptoms may be bone loss, decreased muscle strength, and memory or cognition declines.
Since these symptoms can be signs of other diseases, including depression, they are not sufficient for a diagnosis of female androgen insufficiency until other conditions have been ruled out and two other conditions are met:
There is evidence of adequate estrogen, such as normal cycles in premenopausal women or estrogen replacement therapy in postmenopausal women.
The patient has free testosterone values at or below the lowest quartile of the normal range for her reproductive age.
Since sensitive assays and absolute threshold values of androgens have not been established for women, the panel offered the lowest-quartile cutoff as a “clinically useful, albeit arbitrary, criterion for establishing a diagnosis.”
Androgen assays remain a conundrum, the panel acknowledged.
“There was general agreement that the total testosterone assay was not ideal and some concern about the most popular and frequently performed analogue testosterone assay,” panelist Dr. Richard Spark of the department of endocrinology at Beth Israel Deaconess Medical Center, Boston, said in an interview. “The free testosterone by dialysis is perhaps the most accurate but also the most costly and is not performed by most labs.”
Until better options are commercially available, the panel advised clinicians to assess androgen production and androgen availability by obtaining two out of the following three values: total testosterone and sex hormone–binding globulin (SHBG), free testosterone and SHBG, or free testosterone and total testosterone.
“Ideally, testosterone values should be obtained in the morning hours and in the middle third of the menstrual cycle in normally cycling premenopausal women,” the panelists noted.
The Free Testosterone Index (total T/SHBG) correlates well with free testosterone or bioavailable testosterone, but Free Testosterone Index assays “are not well validated for women,” the statement reported.
The most useful measurement of adrenal androgen production in women is dehydroepiandrosterone sulfate (DHEAS), which is reliable and can be used if a clinician suspects an adrenal cause for androgen insufficiency.
The panel said salivary assays and potential biologic markers for androgen insufficiency were not researched well enough to be considered useful diagnostic measures.
Clinicians were cautioned by the panelists to consider other explanations before considering a trial of androgen replacement, including major life stresses or relationship problems, thyroid disease, metabolic or nutritional deficiencies, other causes of chronic fatigue such as Lyme disease, and psychiatric disorders.
An effort should be made to determine and then correct the underlying cause of the deficiency. Commonly, these can include ovarian, adrenal, or hypothalamic-pituitary problems or drug-related causes, but the cause may be idiopathic.
A practical algorithm for initiating therapy in patients who meet diagnostic criteria was published along with the statement (see box ).
No androgen replacement therapy is currently approved in the United States for women, and the panel suggested that physicians offering testosterone supplementation or DHEAS off label should regularly assess their patient's health in light of potential risks, including lipid changes, estrogenic effects, and effects on the mood, voice, and skin.
Dr. Ray Rosen of the Robert Wood Johnson Medical School organized the panel. Dr. Glenn Braunstein of Cedars-Sinai Medical Center in Los Angeles chaired the consensus report committee.
--------------------------------------------------------------------------------
Algorithm for Deciding Whether To Initiate Androgen Therapy
* Does the woman have symptoms consistent with female androgen insufficiency, such as low libido or decreased energy?
If yes, initiate evaluation.
* Is there an alternative explanation or cause for these symptoms—for example, major depression or chronic fatigue syndrome?
If yes, manage as appropriate.
If no, evaluate further.
* Is the woman in an optimum estrogen state?
If yes, continue evaluation.
If no, initiate estrogen replacement.
* Does the woman have laboratory values that are consistent with a diagnosis of androgen insufficiency?
If yes, continue evaluation, including assessment of at least two of three measures of total testosterone, free testosterone, or sex hormone–binding globulin. To meet the diagnosis, androgen values must be in the lowest quartile for women of reproductive age.
If no, consider alternative treatments or a referral.
* Does the woman have a specific treatable cause for androgen insufficiency, such as oral estrogen or oral contraceptive use?
If yes, treat the specific cause (for example, change medications).
If no, consider a trial of androgen replacement therapy.
Source: Fertil. Steril. 77(4):660-65, 2002
What it does do is to lay down the groundwork for "studies" or "experimental therapies" for women who meet these vague criteria, thereby giving Ob/Gyn's a whole lot more leeway in
prescribing androgenic meds and drawing labs.
--------------------------------------------------------------------------------
Provides management algorithm
New Statement Defines Androgen Insufficiency
Betsy Bates
Los Angeles Bureau
LOS ANGELES — A newly published consensus statement on female androgen insufficiency offers a working definition of the condition and an algorithm for its management.
It also emphasizes an urgent need for development of a practical, affordable assay for assessment of bioavailable testosterone in women. “Current androgen assays are unsatisfactory primarily because of their lack of [either] sensitivity or reliability at the lower ranges of normal,” the document states (Fertil. Steril. 77[4]:660-65, 2002).
Dr. Irwin Goldstein, director of the Center for Sexual Medicine and professor of urology at Boston University, hailed the new guidelines as a “bible,” offering perspective on a topic that has long been underappreciated. His remarks came during a session on female sexuality at the annual meeting of the American College of Obstetricians and Gynecologists.
The panel that wrote the statement consisted of experts in the field from throughout the United States and Australia.
Panelist Dr. Goldstein said that the document may specifically spur interest among ob.gyns. in treating the 60 million women in America who have sexual dysfunction. To date, less than 5% of ob.gyns. have indicated an enthusiasm to get involved in the field, perhaps because it has been marked by a lack of good research to guide their practice.
“Historically, androgens have been identified with masculinity or male sexual function, which has undoubtedly contributed to a lack of recognition of androgen effects in women,” according to the consensus statement, which was written by 19 panelists who attended a conference in June 2001 at the Robert Wood Johnson Medical School in Piscataway, N.J.
“In fact,” the statement continued, “androgens are necessary not only for the development of reproductive function and hormonal homeostasis in women, but they also represent the immediate precursors for the biosynthesis of estrogen. Androgens affect sexual desire, bone density, muscle mass and strength, adipose tissue distribution, mood, energy, and psychological well-being.”
To help guide clinicians, the panel defined androgen insufficiency in women as a pattern of clinical symptoms in the presence of decreased bioavailable testosterone and normal estrogen status.
Symptoms must be present for a diagnosis to be made and can include a diminished sense of well-being or dysphoric mood; persistent, unexplained fatigue; and sexual function changes, including decreases in libido, sexual receptivity, and pleasure. Other potential symptoms may be bone loss, decreased muscle strength, and memory or cognition declines.
Since these symptoms can be signs of other diseases, including depression, they are not sufficient for a diagnosis of female androgen insufficiency until other conditions have been ruled out and two other conditions are met:
There is evidence of adequate estrogen, such as normal cycles in premenopausal women or estrogen replacement therapy in postmenopausal women.
The patient has free testosterone values at or below the lowest quartile of the normal range for her reproductive age.
Since sensitive assays and absolute threshold values of androgens have not been established for women, the panel offered the lowest-quartile cutoff as a “clinically useful, albeit arbitrary, criterion for establishing a diagnosis.”
Androgen assays remain a conundrum, the panel acknowledged.
“There was general agreement that the total testosterone assay was not ideal and some concern about the most popular and frequently performed analogue testosterone assay,” panelist Dr. Richard Spark of the department of endocrinology at Beth Israel Deaconess Medical Center, Boston, said in an interview. “The free testosterone by dialysis is perhaps the most accurate but also the most costly and is not performed by most labs.”
Until better options are commercially available, the panel advised clinicians to assess androgen production and androgen availability by obtaining two out of the following three values: total testosterone and sex hormone–binding globulin (SHBG), free testosterone and SHBG, or free testosterone and total testosterone.
“Ideally, testosterone values should be obtained in the morning hours and in the middle third of the menstrual cycle in normally cycling premenopausal women,” the panelists noted.
The Free Testosterone Index (total T/SHBG) correlates well with free testosterone or bioavailable testosterone, but Free Testosterone Index assays “are not well validated for women,” the statement reported.
The most useful measurement of adrenal androgen production in women is dehydroepiandrosterone sulfate (DHEAS), which is reliable and can be used if a clinician suspects an adrenal cause for androgen insufficiency.
The panel said salivary assays and potential biologic markers for androgen insufficiency were not researched well enough to be considered useful diagnostic measures.
Clinicians were cautioned by the panelists to consider other explanations before considering a trial of androgen replacement, including major life stresses or relationship problems, thyroid disease, metabolic or nutritional deficiencies, other causes of chronic fatigue such as Lyme disease, and psychiatric disorders.
An effort should be made to determine and then correct the underlying cause of the deficiency. Commonly, these can include ovarian, adrenal, or hypothalamic-pituitary problems or drug-related causes, but the cause may be idiopathic.
A practical algorithm for initiating therapy in patients who meet diagnostic criteria was published along with the statement (see box ).
No androgen replacement therapy is currently approved in the United States for women, and the panel suggested that physicians offering testosterone supplementation or DHEAS off label should regularly assess their patient's health in light of potential risks, including lipid changes, estrogenic effects, and effects on the mood, voice, and skin.
Dr. Ray Rosen of the Robert Wood Johnson Medical School organized the panel. Dr. Glenn Braunstein of Cedars-Sinai Medical Center in Los Angeles chaired the consensus report committee.
--------------------------------------------------------------------------------
Algorithm for Deciding Whether To Initiate Androgen Therapy
* Does the woman have symptoms consistent with female androgen insufficiency, such as low libido or decreased energy?
If yes, initiate evaluation.
* Is there an alternative explanation or cause for these symptoms—for example, major depression or chronic fatigue syndrome?
If yes, manage as appropriate.
If no, evaluate further.
* Is the woman in an optimum estrogen state?
If yes, continue evaluation.
If no, initiate estrogen replacement.
* Does the woman have laboratory values that are consistent with a diagnosis of androgen insufficiency?
If yes, continue evaluation, including assessment of at least two of three measures of total testosterone, free testosterone, or sex hormone–binding globulin. To meet the diagnosis, androgen values must be in the lowest quartile for women of reproductive age.
If no, consider alternative treatments or a referral.
* Does the woman have a specific treatable cause for androgen insufficiency, such as oral estrogen or oral contraceptive use?
If yes, treat the specific cause (for example, change medications).
If no, consider a trial of androgen replacement therapy.
Source: Fertil. Steril. 77(4):660-65, 2002
