This is the current release of the guideline.

Based on the evidence, The North American Menopause Society supports the following recommendations regarding testosterone use in postmenopausal women.

• 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 sex hormone-binding globulin (SHBG).
• 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.
• Testosterone 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 intramuscular (IM) testosterone products for women are currently government-approved.
• Pellet and IM testosterone formulations have a risk of excessive dosing. Also, administration may be uncomfortable.
• Testosterone 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 testosterone products should be used with caution because the dosing may be more inconsistent than it is 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 of testosterone therapy should include subjective assessments of sexual response, desire, and satisfaction as well as evaluation for potential adverse effects.
• If adverse events are observed with testosterone therapy, dose reductions are advised. If the adverse events do not diminish with lower doses, therapy should be discontinued.
• Contraindications of testosterone therapy 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 not government-approved should be provided before initiating therapy.

None provided

The type of supporting evidence is not specifically stated for each recommendation. Priority was given to evidence from randomized, controlled trials as well as to systematic reviews and meta-analyses of such trials.

Not applicable: The guideline was not adapted from another source.

2005 Jun 30

The North American Menopause Society - Private Nonprofit Organization

The development of the guideline document was supported by an unrestricted educational grant from Procter & Gamble Pharmaceuticals.

Editorial Board

Board Members

Jan L. Shifren, MD (Chair) Assistant Professor of Obstetrics, Gynecology and Reproductive Biology, Harvard Medical School; Director, Menopause Program, Vincent Obstetrics and Gynecology Service, Massachusetts General Hospital, Boston, MA

Susan R. Davis, MBBS, FRACP, PhD, Chair of Women's Health, Department of Medicine, Central and Eastern Clinical School, Monash University Medical School, Prahran, Victoria, Australia

Lorraine Dennerstein, AO, MBBS, DPM, PhD, FRANZCP, Professor, and Director, Office for Gender and Health, Department of Psychiatry, University of Melbourne, Parkville, Victoria, Australia

Julia R. Heiman, PhD, Director, Kinsey Institute for Research in Sex, Gender and Reproduction; Professor of Psychology and Clinical Psychiatry, Indiana University, Bloomington, IN

Rogerio A. Lobo, MD, Professor of Obstetrics and Gynecology, Columbia University College of Physicians & Surgeons, New York, NY

James A. Simon, MD, Clinical Professor of Obstetrics and Gynecology, George Washington University School of Medicine, Washington, DC

Not stated

This is the current release of the guideline.

This summary was completed by ECRI on October 10, 2005. The information was verified by the guideline developer on December 12, 2005.

This summary is based on content contained in the original guideline, which is subject to terms as specified by the guideline developer. Users are free to download a copy of the materials and information on a single computer for personal, noncommercial use only; provided that any copyright, trademark or other proprietary notices are not removed from any materials and information downloaded. Any other use requires written permission from the guideline developer.