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Use of Testosterone Therapy By Postmenopausal Women: Position Statement of the North American Menopause Society

Posted on: Thursday, 8 September 2005, 18:00 CDT

Testosterone therapy has been shown to improve sexual function in many postmenopausal women, primarily the symptoms of sexual desire, arousal, and orgasmic response, according to the most recent evidence-based Position Statement from The North American Menopause Society (NAMS). The paper, titled "The role of testosterone in postmenopausal women," is published in the September/October 2005 issue of the Society's official journal, Menopause. (An embargoed copy of the Position Statement can be viewed at: http://www.menopause.org/aboutmeno/consensus.htm .)

"NAMS developed this Position Statement to fulfill a need for practical clinical guidelines on the use of testosterone to treat postmenopausal women," said Wulf H. Utian, MD, PhD, NAMS Executive Director. "This paper provides a valuable source of information regarding the physiology of testosterone, its use in clinical trials, patient evaluation, side effects, monitoring while on therapy, and the differences in available products."

Based on clinical trial evidence, postmenopausal women who report decreased sexual desire may be candidates for testosterone therapy, but they should first be evaluated for other causes of their sexual concerns, more appropriately treated with alternative approaches. Conditions that can decrease sexual desire include psychosocial issues (such as stress, fatigue, or relationship conflict), psychological disorders (including depression or anxiety), medical conditions (such as vaginal atrophy or hypothyroidism), and drug use (including antidepressants and alcohol).

"The only current indication for testosterone therapy in postmenopausal women is to treat sexual concerns, primarily decreased sexual desire," said Jan L. Shifren, MD, Chair of the Editorial Board for this Position Statement. "No other use is supported by the scientific literature, including increasing lean body mass, reducing hot flashes, or improving bone density." Dr. Shifren is Assistant Professor of Obstetrics, Gynecology and Reproductive Biology, Harvard Medical School, and Director, Menopause Program, Vincent Obstetrics and Gynecology Service, Massachusetts General Hospital, Boston.

Even though testosterone is an effective treatment for decreased sexual function, low testosterone levels have not been clearly linked to sexual function in postmenopausal women.

Both oral and nonoral (eg, patches, creams, gels) testosterone products have been used in clinical trials. However, essentially no products are government-approved in the United States or Canada for treating sexual dysfunction in women. Therefore, healthcare providers recommend prescription testosterone products intended for other indications in women or products developed for men. Some providers prescribe custom-compounded products.

"Because of the lack of approved products for women, healthcare practitioners recommend products for uses or at doses that have not been rigorously tested in women," Dr. Shifren said. "Women need to know that we have limited information on the risks and benefits of these formulations."

The most common side effects associated with testosterone therapy are facial hair growth and acne. If adverse events are observed, reducing the dose or stopping therapy is advised. The risks associated with long-term use are unknown.

The NAMS Position Statement contains the following recommendations regarding testosterone products:

-- Transdermal patches or topical gels or creams may be preferred over oral products, but only oral and intramuscular (injection) testosterone products for women are currently government-approved.

-- 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 excessive levels.

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

-- 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 tests cannot accurately detect testosterone concentrations at the low values typically found in postmenopausal women.

This Position Statement has been designated a continuing medical education (CME) activity by NAMS. Health professionals can earn up to 2 hours in Category 1 credit.

NAMS is grateful for the unrestricted educational grant from Procter & Gamble Pharmaceuticals that supported the development of this Position Statement.

NAMS is North America's leading nonprofit organization dedicated to promoting women's health and quality of life through an understanding of menopause. The Society's membership of more than 2,000 includes experts from medicine, nursing, sociology, psychology, pharmacy, anthropology, epidemiology, nutrition, education, and basic science - helping NAMS to be the preeminent resource on all aspects of menopause to healthcare providers and the public. The Society can be contacted at P.O. Box 94527, Cleveland, OH 44101; phone 440/442-7550; fax 440/442-2660; e-mail info@menopause.org; Web site www.menopause.org.

(End of advance for release September 14, 2005.)

Source: Business Wire

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