Bioidentical Hormones

“The use of compounded bioidentical hormone
replacement therapies is not recommended
given the issues related to their purity, potency and safety”.1

Umbrella
What may the Bioidentical Hormones Umbrella include?

Depending on the Source (DotS) this Umbrella may include:

  • Bioequivalent Hormone Therapy
  • Bioidentical Hormone Medications
  • Bioidentical Hormone Replacement Therapy (BHRT)
  • Bioidentical Hormone Therapy (BHT)
  • Bioidentical Hormones
  • Bioidenticals
  • Custom-Compounded Bioidentical Hormone Therapy (C-CHT)
  • Custom-Made Bioidentical Hormones
  • Custom-Mixed Bioidentical Hormones
  • Hormone Therapy Alternatives
  • Natural Hormone Therapies
  • Pharmacy Compounded Hormones
  • ‘Compounded’ Bioidentical Hormone Replacement Therapy (cBHRT)
  • ‘Regulated’ Bioidentical Hormone Replacement Therapy (rBHRT)

Bioidentical Hormones

What are bioidentical hormones?

DotS the definition of bioidentical hormones may vary. On page one in Menopausal Hormone Therapy the European Menopause and Andropause Society’s definition is:

“‘Bioidentical hormones’ is a term used to describe plant-derived preparations (like approved MHT drugs) modified to be structurally identical to human hormones such as estradiol and progesterone”.2

Bioidentical Hormone Therapy

What is bioidentical hormone therapy?

DotS the definition of bioidentical hormone therapy may vary. In Menopause FAQs: Hormone Therapy for Menopause Symptoms – Q. I’ve heard about something called bioidentical hormones. What are they? the North American Menopause Society’s (NAMS) definition is:

“The term bioidentical hormone therapy began as a marketing term for custom-compounded hormones. But it is taken to mean hormones that have the same chemical and molecular structure as hormones that are produced in the body”.3

Body-Identical Hormone Therapy

What is body-identical hormone therapy?

DotS the definition of body-identical hormone therapy may vary. In Bioidentical Custom Compounded Hormone Therapy the Australasian Menopause Society’s (AMS) definition is:

“…‘body-identical’ hormone therapy refers to pharmaceutical products that have the same chemical structure as those produced in the human body”.4

Drug Compounding

What is drug compounding?

DotS the definition of drug compounding may vary. In Compounding and the FDA: Questions and Answers – What Is Compounding? the (United States) Food and Drug Administration’s (FDA) definition is:

“Drug compounding is often regarded as the process of combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient. Compounding includes the combining of two or more drugs. Compounded drugs are not FDA-approved”.5

Approved or Not

Are compounded bioidentical hormones approved by individual Country Drug Regulatory bodies for example the FDA?

In Compounding and the FDA: Questions and Answers – Are Compounded Drugs Approved By FDA? the FDA elaborate on:

“Compounded drugs are not FDA-approved. This means that FDA does not verify the safety or effectiveness of compounded drugs. Consumers and health professionals rely on the drug approval process for verification of safety, effectiveness, and quality. Compounded drugs also lack an FDA finding of manufacturing quality before such drugs are marketed”.6

Natural or Not

Are bioidentical hormones natural?

In Bioidentical Hormones: Are They Safer? Are bioidentical or natural hormones safer and more effective than hormones used in traditional hormone therapy for menopause symptoms? the (United States) Mayo Clinic author explains:

“The term “natural” means the hormones in the product come from plant or animal sources. They’re not made in a lab. But many of these products still need to be commercially processed to become bioidentical”.7

In Menopause Management Options: Pharmacy-Compounded Hormones (Bioidentical Hormones) the (Australian) Jean Hailes for Women’s Health (JH) note:

“Some doctors prescribe pharmacy-compounded hormones, which are also known as ‘bioidentical’ hormones. These are mixtures of different hormones made up in compounding pharmacies. The hormones are promoted as ‘natural’ and ‘exactly like our own’, which is not true.

Pharmacy-compounded preparations can contain oestrogens, progesterone and sometimes other hormones such as testosterone. The preparations are made into capsules, creams, gels, drops (applied to the tongue), lozenges or troches (soft square-shaped tablets) that are sucked inside the cheek.

All hormone therapies are manufactured synthetically. Hormones are only natural when they are in the human body”.8

Safe or Not

Are bioidentical hormones safe?

In Bioidentical Hormones: Risks and Benefits – What Are the Risks of Bioidentical Hormones?, published 15 May 2022, the (United States) Cleveland Clinic elaborate on:

“Many healthcare providers who use bioidentical hormones claim they are safer than traditional hormone therapy treatments. But there have been no large research studies of bioidentical hormones to show evidence of this”.9

On page 771 in The 2022 Hormone Therapy Position Statement of The North American Menopause Society, published July 2022, and endorsed by multiply organizations, the NAMS explain:

“There is a dearth of safety and efficacy data with little or no high-quality pharmacokinetic data to provide evidence of safety and efficacy of compounded bioidentical hormone therapy and insufficient evidence to support overall clinical use of compounded bioidentical hormone therapy for treatment of menopause symptoms. Compounded bioidentical hormone therapy presents safety concerns, such as minimal government regulation and monitoring, overdosing and underdosing, presence of impurities and lack of sterility, lack of scientific efficacy and safety data, and lack of a label outlining risks”.10

Testing or Not

Is serum, saliva or urine hormone testing necessary?

On page 771 in The 2022 Hormone Therapy Position Statement of The North American Menopause Society, published July 2022, and endorsed by multiply organizations, the NAMS note:

“Compounded bioidentical hormone therapy has been prescribed or dosed on the basis of serum, salivary, or urine hormone testing; however, the use of such testing to guide hormone therapy dosing is considered unreliable because of differences in hormone pharmacokinetics and absorption, diurnal variation, and interindividual and intraindividual variability”.11

Recommended or Not

Do menopause societies, women’s health organizations and other organization, recommend the use of compounded hormone therapy?

On page four in the Joint Position Statement By the British Menopause Society, Royal College of Obstetricians and Gynaecologists and Society for Endocrinology on Best Practice Recommendations for the Care of Women Experiencing the Menopause, first published online 10 June 2022, one of the recommendations is:

  • “The use of compounded bioidentical hormone replacement therapies is not recommended given the issues related to their purity, potency and safety. The potential benefits of bioidentical hormone therapy can be achieved using conventionally licensed products available through NHS prescribing without having to resort to compounded varieties from specialist pharmacies”.12

In Menopause Management Options: Pharmacy-Compounded Hormones (Bioidentical Hormones) the JH also note:

“We do not recommend the use of pharmacy-compounded menopause hormone therapy”.13

In The 2023 Practitioner’s Toolkit for Managing Menopause: Management – Considerations for All Women At Menopause: Menopausal Hormone Therapy, published online 30 October 2023, the authors explain:

  • “The prescription of individually formulated and compounded hormone preparations is not recommended”.14

Government Approved

Are government approved bioidentical hormones available?

Yes. In Bioidentical Hormone Therapy: Custom Compounded versus Government Approved published in 2020, the NAMS elaborate on:

“If you prefer to treat your bothersome menopause symptoms with hormones that are chemically identical to those you produced naturally before menopause, ask your healthcare provider to prescribe estradiol and progesterone products that are scientifically tested and government approved. Estradiol is available as an oral tablet, skin patch, topical gel, topical spray, and vaginal ring. Low doses of estradiol used in the vagina (to treat vaginal dryness and painful intercourse but not hot flashes) are available as a vaginal tablet, cream, and ring. Progesterone is available as an oral capsule (see table below for product names)”.15

On page 771 in The 2022 Hormone Therapy Position Statement of The North American Menopause Society, published July 2022, and endorsed by multiply organizations, the NAMS also note:

“The term bioidentical hormone therapy (similar to endogenous) can be misleading because there are both government-approved and compounded bioidentical hormone therapies. Government approved (in the United States, FDA-approved) bioidentical hormones include estradiol, estrone, and MP, which are regulated and monitored for purity and efficacy. These are dispensed with package inserts containing extensive product information (based on RCTs) and may include black-box warnings for AEs. In contrast, compounded bioidentical hormone therapies are prepared by a compounding pharmacist using a provider’s prescription. These therapies may combine multiple hormones (estradiol, estrone, estriol, DHEA, testosterone, progesterone) and use untested, unapproved combinations or formulations or are administered in nonstandard or untested routes such as subdermal implants, pellets, or troches”.16

In Menopause Management Options: Pharmacy-Compounded Hormones (Bioidentical Hormones) the JH include:

“Note: in Australia, doctors can prescribe conventional menopause hormone therapies (MHT) that are identical to those hormones made in your body. These products have been thoroughly tested for safety and effectiveness”.17

Health Care Provider

What if I choose to use bioidentical hormones?

If you choose to use bioidentical hormones it may be in your best interest to also choose to tell your health care providers you are doing this. The JH caution:

“It’s important to have a face-to-face meeting with your health practitioner to discuss the risks and benefits of different treatments for menopause”.18

Health Topics A-Z

Where may I find Health Topics A-Z related to Bioidentical Hormones?

In Health Topics A-Z you may find:

Health Topics A-Z

Links

Where may I find Links related to Bioidentical Hormones?

Your Country may have Links similar to:

Links

This Links List to third party websites is neither comprehensive nor exhaustive. Inclusion on this Links List does not imply endorsement or recommendation. Non-inclusion on this Links List does not imply non-endorsement or non-recommendation. Third party websites are not under the control of Meno Martha International Menopause Directory. Third party websites may contain explicit medical images and/or sexual references. Please read Meno Martha International Menopause Directory’s Links Policy before proceeding to a Link. Please contact Webmaster if you experience a problem with a Link.

New or Updated

  1. 20 Years of Data Lead To Changes In Perceptions, Usage of Menopausal HT
  2. Askearlymenopause.org [Ask EM] [+ Video: What Is Early Menopause?]
  3. BMS Statement on Testosterone
  4. BMS TV: Bioidentical Hormones
  5. BMS TV: Hormone Replacement Therapy (HRT)
  6. BMS TV: Testosterone Explained
  7. Bioidentical Custom Compounded Hormone Therapy
  8. Bioidentical HRT [British Menopause Society Consensus Statement, 2019]
  9. Bioidentical Hormones
  10. Bioidentical Hormones
  11. Bioidentical Hormones – Ask Dr Jean
  12. Bioidentical Hormones: Are They Safer?
  13. Complementary/Alternative Therapies for Menopausal Women
  14. Compounded Bioidentical Hormone Therapy
  15. Compounded Bioidentical Hormone Therapy [Video]
  16. Compounding and the FDA: Questions and Answers
  17. Deciding About Hormone Therapy
  18. Deciding About Hormone Therapy Use
  19. Dr Louise Newson: The Truth About the Menopause & HRT
  20. Emerging Research In the Management of Menopausal Symptoms
  21. Fact or Fiction? The Role of Regulated Body-Identical Hormone Therapy for Menopausal Women
  22. Find A Menopause Practitioner [United States and Other]
  23. Find An AMS Doctor [Australasian Menopause Society i.e. Australia and New Zealand]
  24. Find Your Nearest BMS Menopause Specialist [British Menopause Society]
  25. Follicle-Stimulating Hormone (FSH) Levels Test
  26. HRT and Alternatives
  27. HRT: Summary
  28. Hot Flashes
  29. Hot Flashes
  30. Hot Flashes: What Can I Do? [+ Video: What Are the Signs and Symptoms of Menopause?]
  31. How To Find Relief for Hot Flashes At Night
  32. I Forgot To Ask the Doctor – E9: The Menopause: Can Every Woman That Wants It Have HRT?
  33. Is It Really ‘FDA Approved?’ FDA Doesn’t Approve Compounded Drugs
  34. Joint Position Statement by the British Menopause Society, Royal College of Obstetricians and Gynaecologists and Society for Endocrinology on Best Practice Recommendations for the Care of Women Experiencing the Menopause
  35. Later Years (Around 50 Years and Over): Menopause and Post Menopause Health – Hormone Replacement Therapy (HRT) [+ Video: Is HRT Bad for You?]
  36. Later Years (Around 50 Years and Over): Menopause and Post Menopause Health – Signs and Symptoms [+ Video: Talking Menopause With Your GP]
  37. Looking At HRT In Perspective
  38. Luteinizing Hormone (LH) Levels Test
  39. Mayo Clinic Minute: Help With Hot Flashes Due To Menopause [+ Video Courtesy: Mayo Clinic News Network]
  40. Mayo Clinic Minute: Lifestyle Changes To Manage Menopause Symptoms [+ Video]
  41. Menopause
  42. Menopause
  43. Menopause & Herbs
  44. Menopause Management Options: Pharmacy-Compounded Hormones
  45. Menopause Map: Downloadable Resources – My Personal Path Print Tools: Questions for Your Health Care Provider
    Bioidentical Hormones
  46. Menopause Map: Downloadable Resources – My Personal Path Print Tools: Symptom Tracker
  47. Menopause Patient Information [Videos] 3. The Risks & Benefits of HRT
  48. Menopause Patient Information [Videos] 4. The Different Types of HRT
  49. Menopause Preparedness Toolkit Video Series: Treating Vasomotor Symptoms of Menopause
  50. Menopause Symptoms and Relief
  51. Menopause Symptoms: Mayo Clinic Expert Outlines Hormone and Nonhormonal Therapies
  52. Menopause Treatment: Bioidentical Hormones
  53. Menopause Treatments: What Works, What Doesn’t
  54. Menopause What Are the Symptoms?
  55. Menopause and HRT
  56. Menopause, Perimenopause, Hormone Therapy and Other Treatments With Madelyn Butler, MD [Podcast]
  57. Menopause Preparedness Toolkit: A Woman’s Empowerment Guide
  58. Menopause: Diagnosis & Treatment
  59. Menopause: Diagnosis and Management – Information for the Public: Questions To Ask About Menopause – Treatment for Menopausal Symptoms [NICE Guideline]
  60. Menopause: Understanding the Changes and Finding Relief | Dr Susan Davis | The Proof Podcast EP #256
  61. National Academies of Science, Engineering, and Medicine (NASEM) Study on the Clinical Utility of Treating Patients With Compounded “Bioidentical” Hormone Therapy
  62. National Center for Complementary and Integrative Health: Herbs At A Glance
  63. National Center for Complementary and Integrative Health: How Safe Is This Product or Practice?
  64. National Center for Complementary and Integrative Health: Natural Doesn’t Necessarily Mean Safer, or Better
  65. Natural Remedies To Help Manage Perimenopause Symptoms
  66. Natural Therapies
  67. Navigating Menopause: Expert Insights and Solutions | Dr Susan Davis | The Proof Podcast EP 245
  68. Neither Natural Nor Safe: Compounded Bioidentical Hormones Need Better Evidence
  69. Nonhormone Treatments for Hot Flashes and Night Sweats
  70. Office of Dietary Supplements: Black Cohosh
  71. Office of Dietary Supplements: Dietary Supplement Fact Sheets
  72. Safety and Efficacy of Compounded Bioidentical Hormone Therapy (cBHT) In Perimenopausal and Postmenopausal Women: A Systematic Review and Meta-Analysis of Randomized Controlled Trials
  73. The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use (2020)
  74. The North American Menopause Society Releases Its 2022 Hormone Therapy Position Statement
  75. The South African Menopause Society (SAMS) Statement on Compounded (Bioidentical) Menopausal Hormone Therapy
  76. The Truth About Menopause Supplements | Dr Sarah Berry
  77. Therapy for the Effects of Menopause
  78. Tips To Help Manage Menopause Symptoms
  79. Using Natural Therapies In the Menopause Transition – Webinar
  80. Vaginal Dryness
  81. Vaginal Dryness Alternative Treatments
  82. Video Series-2022: Hormone Therapy: Understanding the Risks and Benefits
  83. Video Series-2022: Perimenopause, Signs, Symptoms, and Solutions
  84. Video Series-2023: NAMS 2023 Nonhormone Therapies Position Statement for Bothersome Menopause Symptoms
  85. Video Series-2023: New FDA-Approved Nonhormone Option for the Treatment of Hot Flashes
  86. Videos and Podcasts: Videos – Interviews: A Simple Approach To Menopause: The Menopause Quick Six (www.MQ6.ca)
  87. What Everyone Should Know About Menopause Symptoms
  88. Why Didn’t Anyone Tell Me This? Episode 3: Dr Annice Mukherjee: Your Essential Menopause Toolkit

Sources

Where may I find the Sources quoted?

You may find the Sources quoted at:

Sources

  1. Hamoda, H., Mukherjee, A., Morris, E., Baldeweg, S. E., Jayasena, C. N., Briggs, P., Moger, S. Joint Position Statement By the British Menopause Society, Royal College of Obstetricians and Gynaecologists and Society for Endocrinology on Best Practice Recommendations for the Care of Women Experiencing the Menopause. First Published Online 10 June 2022:3-4. https://journals.sagepub.com/doi/full/10.1177/20533691221104879 Accessed: 23 November 2023
  2. Menopausal Hormone Therapy. 2022:1. European Menopause and Andropause Society https://emas-online.org/wp-content/uploads/2022/05/Menopausal-hormone-therapy.pdf Accessed: 23 November 2023
  3. Menopause FAQs: Hormone Therapy for Menopause Symptoms – Q. I’ve heard about something called bioidentical hormones. What are they? North American Menopause Society https://www.menopause.org/for-women/menopause-faqs-hormone-therapy-for-menopause-symptoms Accessed: 23 November 2023
  4. Bioidentical Custom Compounded Hormone Therapy. Content Updated: May 2018. Australasian Menopause Society https://www.menopause.org.au/hp/information-sheets/212-bioidentical-hormones-for-menopausal-symptoms Accessed: 23 November 2023
  5. Compounding and the FDA: Questions and Answers – What Is Compounding? Content Current As of: 29 June 2022. Food and Drug Administration https://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/pharmacycompounding/ucm339764.htm Accessed: 23 November 2023
  6. Compounding and the FDA: Questions and Answers – What Is Compounding? Content Current As of: 29 June 2022. Food and Drug Administration https://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/pharmacycompounding/ucm339764.htm Accessed: 23 November 2023
  7. Burnett, T. Bioidentical Hormones: Are They Safer? 07 December 2022. https://www.mayoclinic.org/diseases-conditions/menopause/expert-answers/bioidentical-hormones/faq-20058460 Accessed: 23 November 2023
  8. Menopause Management Options: Pharmacy-Compounded Hormones (Bioidentical Hormones). Last Updated: 04 September 2023 | Last Reviewed: 19 August 2022. Jean Hailes for Women’s Health https://jeanhailes.org.au/health-a-z/menopause/menopause-management/ Accessed: 23 November 2023
  9. Bioidentical Hormones: Risks and Benefits – What Are the Risks of Bioidentical Hormones? 15 May 2022. Cleveland Clinic https://my.clevelandclinic.org/health/articles/15660-bioidentical-hormones Accessed: 23 November 2023
  10. The 2022 Hormone Therapy Position Statement of The North American Menopause Society. July 2022:771. North American Menopause Society https://www.menopause.org/docs/default-source/professional/nams-2022-hormone-therapy-position-statement.pdf Accessed: 23 November 2023
  11. The 2022 Hormone Therapy Position Statement of The North American Menopause Society. July 2022:771. North American Menopause Society https://www.menopause.org/docs/default-source/professional/nams-2022-hormone-therapy-position-statement.pdf Accessed: 23 November 2023
  12. Hamoda, H., Mukherjee, A., Morris, E., Baldeweg, S. E., Jayasena, C. N., Briggs, P., Moger, S. Joint Position Statement By the British Menopause Society, Royal College of Obstetricians and Gynaecologists and Society for Endocrinology on Best Practice Recommendations for the Care of Women Experiencing the Menopause. First Published Online 10 June 2022:3-4. https://journals.sagepub.com/doi/full/10.1177/20533691221104879 Accessed: 23 November 2023
  13. Menopause Management Options: Pharmacy-Compounded Hormones (Bioidentical Hormones). Last Updated: 04 September 2023 | Last Reviewed: 19 August 2022. Jean Hailes for Women’s Health https://jeanhailes.org.au/health-a-z/menopause/menopause-management/ Accessed: 23 November 2023
  14. Davis, S. R., Taylor, S., Hemachandra, C., Magraith, K., Ebeling, P. R., Jane, F., and Islam, R. M. The 2023 Practitioner’s Toolkit for Managing Menopause: Management – Considerations for All Women At Menopause: Menopausal Hormone Therapy. Published Online: 30 October 2023 https://www.tandfonline.com/doi/full/10.1080/13697137.2023.2258783 Accessed: 24 November 2023
  15. Bioidentical Hormone Therapy: Custom Compounded versus Government Approved. 2020. North American Menopause Society https://www.menopause.org/docs/default-source/2015/mn-bioidenticals.pdf Accessed: 23 November 2023
  16. The 2022 Hormone Therapy Position Statement of The North American Menopause Society. July 2022:771. North American Menopause Society https://www.menopause.org/docs/default-source/professional/nams-2022-hormone-therapy-position-statement.pdf Accessed: 23 November 2023
  17. Menopause Management Options: Pharmacy-Compounded Hormones (Bioidentical Hormones). Last Updated: 04 September 2023 | Last Reviewed: 19 August 2022. Jean Hailes for Women’s Health https://jeanhailes.org.au/health-a-z/menopause/menopause-management/ Accessed: 23 November 2023
  18. Menopause Management Options: Pharmacy-Compounded Hormones (Bioidentical Hormones). Last Updated: 04 September 2023 | Last Reviewed: 19 August 2022. Jean Hailes for Women’s Health https://jeanhailes.org.au/health-a-z/menopause/menopause-management/ Accessed: 23 November 2023
Topic Last Updated: 23 November 2023 – Topic Last Reviewed: 23 November 2023

Print Friendly, PDF & Email
/by