Effective Date

October 1, 2012

Description of Change

The use of compounded bioidentical hormone replacement therapy to treat the symptoms of menopause is considered investigational.

Background

Compounded bioidentical hormone products have been claimed to be safer and more effective than FDA-approved menopausal hormone therapy (MHT) drugs. At the current time, there is lack of credible medical and scientific evidence to support these claims. Additional well-designed and controlled clinical trials are needed to support the efficacy and safety of custom-compounded hormone products and to provide evidence of improved net health outcomes over conventional hormone therapies.