COMMENTARY

Letter to the Editor in Response to "Omissions, Biases, and Nondisclosed Conflicts of Interest: Is There a Hidden Agenda in the NAMS Position Statement?"

George I. Gorodeski, MD, PhD; Marilyn L. Rothert, PhD, RN, FAAN; Victor W. Henderson, MD, MS; Marcie K. Richardson, MD; Robert R. Freedman, PhD; J. Chris Gallagher, MD; Steven R. Goldstein, MD; Bruce Kessel, MD; JoAnn V. Pinkerton, MD; Nancy K. Reame, MSN, PhD, FAAN; Cynthia A. Stuenkel, MD; Leon Speroff, MD; Isaac Schiff, MD; Wulf H. Utian, MD, PhD; The North American Menopause Society 2005/2006 Board Of Trustees

Disclosures

November 17, 2005

In response to Dr. Leonore Tiefer's article that appears in Contemporary Issues in Ob/Gyn & Women's Health, Medscape General Medicine,[1] The North American Menopause Society (NAMS) stands by its Position Statement, "The role of testosterone therapy in postmenopausal women," developed by a panel of acknowledged experts on the subject through a transparent process of evidence-based analysis of the current literature. Full disclosure of the panelists was published in the facing page of the Position Statement (page 496) in our journal Menopause, Volume 12, Number 5 (Nov/Dec), 2005.

The conclusions reached through this scientific, evidence-based analysis are:

  • Postmenopausal women may be candidates for testosterone therapy if they present with symptoms of decreased sexual desire associated with personal distress and have no other identifiable cause for their sexual concerns.

  • Testosterone therapy without concomitant estrogen therapy cannot be recommended, because there are no data on the safety and efficacy of testosterone therapy in women not using concomitant estrogen.

  • Laboratory testing of testosterone levels should be used only to monitor for supraphysiologic testosterone levels before and during therapy, not to diagnose testosterone insufficiency. Laboratory assays are not accurate for detecting testosterone concentrations at the low values typically found in postmenopausal women, and no testosterone level has been clearly linked to a clinical syndrome of hypoandrogenism or testosterone insufficiency. Oral methyltestosterone cannot be measured by standard assays.

  • Testosterone values vary from laboratory to laboratory. In assessing results of testosterone testing, clinicians should use the reference ranges provided by the testing laboratory.

  • The simplest and most readily available clinical estimate of free testosterone is the free testosterone index, calculated from total testosterone and SHBG [sex hormone binding globulin].

  • The Sodergard equation for free testosterone uses total testosterone, SHBG, and albumin. Although it is a more complex formula, it provides a more accurate calculation than the free testosterone index. It is an option to consider if the testing laboratory can provide the calculation.

  • Salivary testing is not considered to be a reliable measure of testosterone levels.

  • Before initiating testosterone treatment, baseline profiles for serum lipids and liver function tests should be established and retesting at 3 months considered. If stable, annual testing is advised.

  • Testosterone therapy should be administered at the lowest dose for the shortest time that meets treatment goals.

  • Transdermal patches and topical gels or creams may be preferred over oral products based on their avoidance of first-pass hepatic effects documented with oral formulations. However, only oral and IM [intramuscular] testosterone products for women are currently government-approved.

  • Pellet and IM formulations have a risk of excessive dosing. Also, administration may be uncomfortable.

  • Products formulated specifically for men provide excessive doses for women and should not be used unless doses are reduced considerably and blood testosterone levels are monitored closely for supraphysiologic levels.

  • Custom-compounded products should be used with caution because the dosing may be more inconsistent than with government-approved products.

  • There are insufficient data for any conclusions to be made regarding the efficacy and safety of testosterone therapy exceeding 6 months.

  • Therapeutic monitoring should include subjective assessments of sexual response, desire, and satisfaction as well as evaluation for potential adverse effects.

  • If adverse events are observed, dose reductions are advised. If the adverse events do not diminish with lower doses, therapy should be discontinued.

  • Contraindications are focused primarily on those associated with estrogen therapy. However, testosterone therapy should not be initiated in postmenopausal women with breast or uterine cancer or with cardiovascular or liver disease.

  • Counseling regarding the potential risks and benefits of testosterone use and the limitations of formulations that are not government-approved should be provided before initiating therapy.

NAMS strongly recommends that the full Position Statement be read.

Submitted by,

Board of Trustees
The North American Menopause Society
Email: info@menopause.org

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