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This version published online on September 19, 2006
Journal of Clinical Endocrinology & Metabolism, doi:10.1210/jc.2006-0740
A more recent version of this article appeared on December 1, 2006
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Submitted on April 5, 2006
Accepted on September 8, 2006

Controversies Regarding Transdermal Androgen Therapy in Postmenopausal Women

Shehzad Basaria MD and Adrian S. Dobs MD, MHS*

Department of Medicine, Division of Endocrinology & Metabolism, The Johns Hopkins University School of Medicine

* To whom correspondence should be addressed. E-mail: adobs{at}jhmi.edu.

Context: Recently, the field of androgen therapy in postmenopausal women has received much attention and press. Although the ovary ceases to produce follicles and estrogen at menopause, it continues to produce androgens. Hence, many oophorectomized women complain of sexual dysfunction (despite adequate estrogenization). Previous studies of non-transdermal testosterone replacement have shown an improvement in libido and sexual frequency, though at the cost of supraphysiological testosterone levels. Transdermal testosterone patch (IntrinsaTM) was developed to deliver physiological amount of testosterone. In 2004, the FDA voted not to approve IntrinsaTM until long-term safety data are available.

Evidence Acquisition: Recent trials of IntrinsaTM in postmenopausal women were included. A MEDLINE search was conducted for articles published over the last 40 yr based on the key words androgen therapy/replacement and postmenopausal women. Relevant placebo-controlled trials of non-transdermal androgen therapy in postmenopausal women were also reviewed.

Evidence Synthesis: Early results from industry-funded trials show that transdermal testosterone therapy results in only moderate (though statistically significant) improvement in libido in surgically menopausal women (on estrogen). However, the published data are of short duration (24 weeks). Hence, long-term safety in these women remains unclear.

Conclusion: We recommend a short-term trial (not to exceed 24 weeks) of transdermal testosterone therapy (once approved) in surgically menopausal (estrogenized) women with distressful sexual dysfunction. Until the patch gets approval, a short trial of oral methyltestosterone in deserving estrogenized women may be justified.







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