Bioidentical Hormones for Menopausal Therapy

Cynthia K Sites

Disclosures

Women's Health. 2008;4(2):163-171. 

In This Article

Conclusion

Compounded estrogen products have increased in popularity in recent years, possibly due in part to endorsements by celebrities and to health concerns regarding conjugated estrogens used in the Women"s Health Initiative studies and HERS. However, no large trials have reported on the efficacy or adverse events of these products compared with placebo (including pills, sublinguals, transdermal creams or gels). FDA-approved trials of commercial patented low-dose gels or patches releasing estradiol can not be generalized to include compounded products, since the absorption of estradiol from the cream or gel formulation used by compounding pharmacies through the skin has not been tested. FDA-approved estradiol gels such as Elestrin use a patented hydroalcoholic base. It is completely unknown how estriol and estradiol are absorbed from compounded gels and creams, whether the various compounding bases used have an impact on absorption, and whether compounded hormones are more effective than placebo compounded gels or creams in relieving menopause symptoms.

Little information is available with regard to compounded progesterone, although it appears that in pharmacokinetic studies, area under the curve for serum progesterone is higher if progesterone is compounded in an emulsion-type base transdermal product compared with a lipophilic or hydrophilic base.[48] Transdermal delivery of progesterone for menopausal symptoms could be preferable to vaginal delivery, since the elimination half-life is 30-40 h with transdermal delivery regardless of type of base, compared with 9-14 h with vaginal suppositories.[49,50] Further information is needed to determine the effectiveness of compounded progesterone for menopausal symptoms and with regard to efficacy to induce secretory endometrial changes and prevent endometrial hyperplasia.

In the past, the FDA has not regulated compounded hormones because they are considered a "supplement" since they are "metabolites".[54] The FDA has a great interest in regulating these products as their popularity has increased, but have been opposed by the American Pharmacy Association, who claims their right to compound. The Endocrine Society issued a position statement in October 2006 asking for greater oversight of all "bioidentical" hormones, whether FDA-approved or compounded, to further understand the safety and efficacy of the products.

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