The U.S. Food and Drug Administration (FDA) has approved dozens of hormone therapy products for men and women, including estrogen, progesterone, testosterone, and related compounds. These products have been reviewed for safety and efficacy and are indicated for treatment of symptoms resulting from hormonal changes associated with menopause or other endocrine-based disorders. In recent decades, an increasing number of health care providers and patients have turned to custom-formulated, or compounded, drug preparations as an alternative to FDA-approved drug products for hormone-related health concerns. These compounded hormone preparations are often marketed as "bioidentical" or "natural" and are commonly referred to as compounded bioidentical hormone therapy (cBHT).
In light of the fast-growing popularity of cBHT preparations, the clinical utility of these compounded preparations is a substantial public health concern for various stakeholders, including medical practitioners, patients, health advocacy organizations, and federal and state public health agencies. This report examines the clinical utility and uses of cBHT drug preparations and reviews the available evidence that would support marketing claims of the safety and effectiveness of cBHT preparations. It also assesses whether the available evidence suggests that these preparations have clinical utility and safety profiles warranting their clinical use and identifies patient populations that might benefit from cBHT preparations in lieu of FDA-approved BHT.
National Academies of Sciences, Engineering, and Medicine. 2020. The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. https://doi.org/10.17226/25791.
|2 An Overview of Compounding||29-42|
|3 Regulatory Framework for Compounded Preparations||43-74|
|4 Reproductive Steroid Hormones: Synthesis, Structure, and Biochemistry||75-90|
|5 Compounded Bioidentical Hormone Preparations||91-116|
|6 Bioavailability of Compounded Bioidentical Hormone Therapy Preparations||117-136|
|7 The Safety and Effectiveness of Compounded Bioidentical Hormone Therapy||137-172|
|8 The Use of Compounded Bioidentical Hormone Therapy||173-216|
|9 Clinical Utility and Recommendations||217-228|
|Appendix A: Study Approach||229-238|
|Appendix B: Study Methods||239-246|
|Appendix C: Glossary||247-252|
|Appendix D: Biosketches||253-262|
|Appendix E: 503A and 503B Distribution Supplement||263-264|
|Appendix F: Compounded Bioidentical Hormone Therapy Formulations with a Single Active Ingredient||265-288|
|Appendix G: Compounded Bioidentical Hormone Therapy Formulations with Two or More Active Ingredients||289-308|
|Appendix H: Boxed Warnings on U.S. Food and Drug AdministrationApproved Estrogen and Testosterone Products||309-312|
The Chapter Skim search tool presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter. You may select key terms to highlight them within pages of each chapter.
The National Academies Press (NAP) has partnered with Copyright Clearance Center's Rightslink service to offer you a variety of options for reusing NAP content. Through Rightslink, you may request permission to reprint NAP content in another publication, course pack, secure website, or other media. Rightslink allows you to instantly obtain permission, pay related fees, and print a license directly from the NAP website. The complete terms and conditions of your reuse license can be found in the license agreement that will be made available to you during the online order process. To request permission through Rightslink you are required to create an account by filling out a simple online form. The following list describes license reuses offered by the National Academies Press (NAP) through Rightslink:
Click here to obtain permission for the above reuses. If you have questions or comments concerning the Rightslink service, please contact:
Rightslink Customer Care
Tel (toll free): 877/622-5543
To request permission to distribute a PDF, please contact our Customer Service Department at 800-624-6242 for pricing.
To request permission to translate a book published by the National Academies Press or its imprint, the Joseph Henry Press, pleaseclick here to view more information.