80 MG Progesterone Cream Raises Blood Levels Significantly
Higher doses or progeserone cream are well absorbed, which may place a woman into a range of progeserone that is higher than her normal production of the hormone.
Study Title:Over-the-counter progesterone cream produces significant drug exposure compared to a food and drug administration-approved oral progesterone product.
Progesterone products are available in prescription form as well as over-the-counter (OTC) topical preparations sold for “cosmetic” uses. In a randomized study design, the authors compared the drug exposure from an OTC progesterone cream to a Food and Drug Administration-approved oral preparation at the labeled daily doses recommended for each product. Twelve healthy postmenopausal women received 200-mg oral progesterone capsules once daily for 12 days or progesterone cream 40 mg twice daily for 12 days. At steady state (day 12 of each phase), whole-blood samples were collected over 24 hours (oral progesterone) or 12 hours (topical progesterone) and assayed for total progesterone concentration. No significant differences were found in dose-normalized 24-hour progesterone exposure comparing the cream to oral capsules (median AUC(0-24) 12.5 ng x h/mL vs 10.5 ng x h/mL, respectively; P = .81). In light of the potential risks associated with long-term progesterone use, the authors question whether topical progesterone products should be available OTC.
Hermann AC, Nafziger AN, Victory J, Kulawy R, Rocci ML Jr, Bertino JS Jr. Over-the-counter progesterone cream produces significant drug exposure compared to a food and drug administration-approved oral progesterone product. J Clin Pharmacol. 2005 June 45(6):614-9.
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