Global Consensus Position Statement on the Use of Testosterone Therapy for Women

Susan R. Davis; Rodney Baber; Nicholas Panay; Johannes Bitzer; Sonia Cerdas Perez; Rakibul M. Islam; Andrew M. Kaunitz; Sheryl A. Kingsberg; Irene Lambrinoudaki; James Liu; Sharon J. Parish; JoAnn Pinkerton; Janice Rymer; James A. Simon; Linda Vignozzi; Margaret E. Wierman

Disclosures

J Clin Endocrinol Metab. 2019;104(10):4660-4666. 

In This Article

Summary and Key Messages

The international panel concluded the only evidence-based indication for testosterone therapy for women is for the treatment of HSDD, with available data supporting a moderate therapeutic effect. There are insufficient data to support the use of testosterone for the treatment of any other symptom or clinical condition, or for disease prevention.

Meta-analyses of the available data show no severe adverse events during physiological testosterone use, with the caveat that women at high cardiometabolic risk were excluded from study populations. The safety of long-term testosterone therapy has not been established.

It was considered of utmost importance that the diagnosis of HSDD involves a full clinical assessment and that other factors contributing to FSD must be identified and addressed before testosterone therapy is initiated.[10,11] A blood total testosterone level should not be used to diagnose HSDD. Treatment should only be with formulations that achieve blood concentrations of testosterone that approximate premenopausal physiological concentrations. As no approved female product is presently approved by a national regulatory body, male formulations can be judiciously used in female doses and blood testosterone concentrations must be monitored regularly. The panel recommended against the use of compounded testosterone.

The panel highlighted the pressing need for more research into testosterone therapy for women and the development and licensing of products indicated specifically for women.

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