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Clinical Utility of Treating Patients with Compounded “Bioidentical Hormone Replacement Therapy”

Completed

In recent years, an increasing number of health care providers and patients have turned to compounded drugs for the treatment of hormone-related health concerns. These products are often marketed as “bioidentical” or “natural” and are commonly referred to as compounded “Bioidentical Hormone Replacement Therapy” (cBHRT). These compounded preparations are often marketed as safer alternatives to the FDA-approved hormone products; however, the FDA does not review or approve compounded preparations for safety, quality, or effectiveness. As a result, FDA asked the National Academies to convene a consensus study to evaluate the safety, effectiveness, use, and overall clinical utility of cBHRT.

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