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Over-the-Counter Progesterone Cream Produces Significant Drug Exposure Compared to a Food and Drug Administration–Approved Oral Progesterone Product

From the Department of Medicine (Dr Hermann, Dr Nafziger, Dr Bertino) and Clinical Pharmacology Research Center, Research Institute (Dr Nafziger, Ms Victory, Dr Bertino), Bassett Healthcare, Cooperstown, New York, and Prevalere Life Sciences, Inc, Whitesboro, New York (Mr Kulawy, Mr Rocci).

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·h/mL vs 10.5 ng·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.

Key Words: Progesterone • women's health • topical therapy

Address for reprints: Joseph S. Bertino, Jr, PharmD, FCP, Ordway Clinical Research, 150 New Scotland Avenue, Albany, NY 12208.