Compounded Bioidentical Menopausal Hormone Therapy

Publication Date: November 1, 2023
Last Updated: January 19, 2024

Summary of Consensus Recommendations

Safety and Efficacy of Custom-Compounded Hormone Therapy

There is a lack of high-quality data on the safety and efficacy of custom-compounded bioidentical hormone therapy for the management of menopausal symptoms. Compounded bioidentical menopausal hormone therapy should not be prescribed routinely when FDA-approved formulations exist.
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There is no FDA-approved testosterone formulation for the management of menopausal symptoms. Clinicians and patients should use a shared decision-making framework when considering the use of compounded testosterone for this indication. Based on the lack of safety data and inability to remove the pellet, ACOG recommends preparations other than pellet therapy for the delivery of testosterone.
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Accuracy of Hormone Level Testing

Data on the interpretation of adjunct hormone tests for prescribing and dosing compounded bioidentical menopausal hormone therapy are limited; thus, these tests are not recommended for these indications.
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Patient Counseling

Clinicians should counsel patients that FDA-approved menopausal hormone therapies are recommended for the management of menopausal symptoms over compounded bioidentical menopausal hormone therapy preparations.
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If a patient requests the use of compounded bioidentical menopausal hormone therapy, clinicians should educate them on the lack of FDA approval of these preparations and their potential risks and benefits, including the risks specific to compounding.
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Recommendation Grading

Disclaimer

The information in this patient summary should not be used as a substitute for professional medical care or advice. Contact a health care provider if you have questions about your health.

Overview

Title

Compounded Bioidentical Menopausal Hormone Therapy

Authoring Organization

Publication Month/Year

November 1, 2023

Last Updated Month/Year

January 19, 2024

Document Type

Consensus

Country of Publication

US

Document Objectives

SUMMARY: Many compounding pharmacies use the phrase “bioidentical hormone” as a marketing term to imply that these preparations are natural and, thus, safer and more effective than U.S. Food and Drug Administration (FDA)–approved menopausal medications that use bioidentical or synthetic hormones or both. However, evidence to support marketing claims of safety and effectiveness is lacking. Compounded bioidentical menopausal hormone therapy should not be prescribed routinely when FDA-approved formulations exist. Clinicians should counsel patients that FDA-approved menopausal hormone therapies are recommended for the management of menopausal symptoms over compounded bioidentical menopausal hormone therapy. If a patient requests the use of compounded bioidentical menopausal hormone therapy, clinicians should educate them on the lack of FDA approval of these preparations and their potential risks and benefits, including the risks specific to compounding. To truly understand the benefits and harms of compounded bioidentical menopausal hormone therapy, high quality placebo-controlled randomized controlled trials with long-term follow-up comparing custom-compounded products with FDA-approved menopausal hormone therapy are needed.
 

Inclusion Criteria

Female, Older adult

Health Care Settings

Ambulatory

Intended Users

Nurse, nurse practitioner, community pharmacist, health systems pharmacist, physician, physician assistant

Scope

Counseling, Management

Diseases/Conditions (MeSH)

D008593 - Menopause

Keywords

menopause, hormonal therapy, biosimilar, bioidentical, compounded hormonal therapy

Supplemental Methodology Resources

Evidence Tables, Data Supplement

Methodology

Number of Source Documents
25
Literature Search Start Date
November 1, 2000
Literature Search End Date
April 1, 2023