Which brands of progesterone are bioidentical?

Bioidentical progesterone is chemically and structurally identical to the hormone produced naturally by the body. For women seeking hormone replacement therapy, it is crucial to understand that both FDA-approved brands and custom-compounded formulations exist, each with significant differences in regulation and oversight.

Quick Summary

Several brands of progesterone are bioidentical and FDA-approved, including Prometrium, Crinone, and Endometrin. Custom-compounded bioidentical hormones are not regulated by the FDA and lack standardized safety and effectiveness testing.

Key Points

• FDA-Approved vs. Compounded: Bioidentical progesterone is available through standardized FDA-approved brands like Prometrium and Crinone, or through custom-compounded preparations, which are not regulated by the FDA.

• Specific Brand Examples: Key FDA-approved bioidentical progesterone brands include oral Prometrium, vaginal gels Crinone and Endometrin, and the combination product Bijuva.

• FDA Regulation and Safety: FDA-approved bioidentical hormones are tested for safety and efficacy in clinical trials, while custom-compounded versions lack this oversight, leading to concerns about consistency and risk.

• Compounded Hormones: Custom-made compounded bioidentical hormones (cBHT) can vary in potency and purity, and their long-term safety is not fully understood due to the lack of large-scale studies.

• Professional Guidance: Major medical societies recommend using FDA-approved bioidentical hormone therapies due to the verifiable quality, safety, and efficacy data, discouraging the routine use of unregulated compounded products.

• Origin of Hormones: Although sourced from plants like soy or yams, both FDA-approved and compounded bioidentical hormones are lab-processed to be structurally identical to human hormones.

What Is Bioidentical Progesterone?

Bioidentical hormones are molecules that are an exact structural match for the hormones naturally produced by the human body. The term is often used to describe hormone replacement therapy (HRT) derived from plant sources like soy or yams, which are then processed in a lab to create a molecularly identical version of a human hormone. This is distinct from synthetic hormones, or progestins, which have a different molecular structure and may have different effects and safety profiles in the body.

There are two main types of bioidentical progesterone: FDA-approved products and custom-compounded preparations. The key difference lies in their manufacturing process and regulatory oversight, which has significant implications for safety and consistency.

FDA-Approved Bioidentical Progesterone Brands

The U.S. Food and Drug Administration (FDA) has approved specific brands and generic forms of bioidentical micronized progesterone. These products undergo rigorous testing for safety, effectiveness, and consistency before they can be sold.

• Prometrium (Oral Capsule): This is a brand name for oral micronized progesterone available in 100 mg and 200 mg capsules. It is often prescribed for postmenopausal women with an intact uterus who are also taking estrogen, to protect the uterine lining from overgrowth, and for the treatment of secondary amenorrhea. A generic version, Progesterone Micronized, USP, is also widely available.
• Crinone (Vaginal Gel): A bioidentical progesterone vaginal gel used for fertility treatments as part of an assisted reproductive technology (ART) program. Crinone is also prescribed for secondary amenorrhea.
• Endometrin (Vaginal Insert): These ovules are prescribed to support embryo implantation and early pregnancy as part of ART treatment for infertile women.
• Bijuva (Combination Oral Capsule): This medication combines bioidentical estradiol and bioidentical micronized progesterone in a single oral capsule. It is FDA-approved for treating moderate to severe hot flashes related to menopause.

Custom-Compounded Bioidentical Hormones

Compounded bioidentical hormone therapy (cBHT) is created by a compounding pharmacy, which custom-mixes preparations for individual patients based on a doctor's prescription. While the base ingredients may be FDA-approved, the final compounded product is not regulated or approved by the FDA. This practice is controversial within the medical community for several reasons.

• Lack of Standardization: The strength and purity of compounded hormones can vary significantly, even between different batches from the same pharmacy. There are no mandated reporting requirements for adverse effects, which makes it difficult to collect reliable safety data.
• Delivery Methods: Compounded bioidentical progesterone is often available in a variety of forms, such as creams, gels, and lozenges, which offer different absorption rates. However, the efficacy and safety of these delivery methods are not supported by large-scale clinical trials.
• Professional Recommendations: Major medical organizations, including the American College of Obstetricians and Gynecologists (ACOG), the North American Menopause Society (NAMS), and the Endocrine Society, caution against the routine use of cBHT. They recommend FDA-approved formulations due to their verified quality and safety data.

Bioidentical Progesterone vs. Synthetic Progestins

It is important to distinguish bioidentical progesterone from synthetic progestins, which are not molecularly identical to the body's natural hormone. The Women's Health Initiative study, which raised concerns about risks associated with HRT, primarily used non-bioidentical hormone formulations.

Comparison of FDA-Approved and Compounded Bioidentical Progesterone

Feature	FDA-Approved Bioidentical Progesterone	Compounded Bioidentical Progesterone (cBHT)
Regulation	FDA-approved and strictly regulated for safety, efficacy, and quality.	Not FDA-approved or regulated; overseen at the state level.
Dosage Consistency	Standardized, uniform dosages ensuring consistent potency and absorption.	Dosing can be inconsistent and may vary between batches.
Efficacy and Safety	Tested in large, controlled clinical trials to confirm safety and effectiveness.	Lacks large-scale clinical trials; limited evidence to support claims of improved safety or efficacy.
Formulations	Limited to specific FDA-approved forms, such as oral capsules, vaginal gels, or inserts.	Customizable formulations (creams, gels, capsules) and dosages.
Cost and Insurance	Often more affordable and typically covered by insurance plans.	Generally more expensive and rarely covered by health insurance.
Medical Consensus	Recommended by major medical organizations.	Cautioned against for routine use by medical societies due to lack of oversight and data.

Conclusion

For those considering bioidentical progesterone, FDA-approved brands offer a regulated and thoroughly tested option backed by clinical data. These include oral options like Prometrium and combination therapies like Bijuva, as well as vaginal products like Crinone and Endometrin. While custom-compounded alternatives may appeal to those seeking individualized treatment, they lack FDA oversight, standard quality controls, and robust safety data. It is essential for patients to have an informed discussion with their healthcare provider to determine the most appropriate and safest form of hormone therapy based on their individual health needs and medical history. The American College of Obstetricians and Gynecologists has released a clinical consensus on the topic, which can be a helpful resource for further reading.

Frequently Asked Questions

What is the difference between bioidentical progesterone and synthetic progestins?

Bioidentical progesterone is chemically and structurally identical to the hormone produced by the human body, whereas synthetic progestins are chemically altered and have a different molecular structure.

Are all bioidentical hormones FDA-approved?

No. While specific bioidentical progesterone products like Prometrium, Crinone, and Endometrin are FDA-approved, custom-compounded bioidentical hormone therapies are not regulated by the FDA.

Which brands of oral progesterone are bioidentical and FDA-approved?

Prometrium, and its generic form, micronized progesterone (USP), are the primary oral bioidentical progesterone medications that are FDA-approved.

What are the risks associated with compounded bioidentical progesterone?

Custom-compounded bioidentical hormones carry risks due to a lack of FDA oversight. These risks include potential for inconsistent dosing, varying potency and purity, and limited data on their safety and long-term effects.

Why do some people choose compounded bioidentical hormones?

Some individuals opt for compounded preparations believing they offer more individualized dosages or non-standard delivery methods like creams. However, these preparations lack the clinical evidence for safety and effectiveness that FDA-approved products have.

Is bioidentical progesterone safer than conventional hormone therapy?

There is no definitive evidence proving that bioidentical hormone therapy is inherently safer than conventional hormone therapy. Studies on compounded versions, in particular, lack the data to support such claims.

Does insurance cover FDA-approved bioidentical progesterone?

FDA-approved bioidentical progesterone products like Prometrium and its generic equivalents are typically covered by most insurance plans, making them more affordable than non-regulated compounded versions.