Conclusion 7-3

There is a dearth of high-quality evidence—data from studies that would meet FDA's requirements for granting regulatory approval to a drug product—available to establish whether compounded bioidentical hormone therapy preparations are safe and effective for their prescribed uses.

Conclusion 7-4

Well-designed and properly controlled clinical trials are needed to provide reliable evidence about the safety and effectiveness of compounded bioidentical hormone therapy preparations.

Conclusion 7-5

The majority of marketing claims about the safety and effectiveness of compounded bioidentical hormone therapy preparations, whether in absolute terms or in comparison to FDA-approved bioidentical hormone therapy, are not supported by evidence from well-designed, properly controlled studies.

From: 7, The Safety and Effectiveness of Compounded Bioidentical Hormone Therapy

Cover of The Clinical Utility of Compounded Bioidentical Hormone Therapy
The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use.
National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Health Sciences Policy; Committee on the Clinical Utility of Treating Patients with Compounded Bioidentical Hormone Replacement Therapy; Jackson LM, Parker RM, Mattison DR, editors.
Washington (DC): National Academies Press (US); 2020 Jul 1.
Copyright 2020 by the National Academy of Sciences. All rights reserved.

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