title: Over-the-counter progesterone cream produces significant drug exposure compared to a food and drug administration-approved oral progesterone product.
abstract: 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.
authors.affiliation: Department of Medicine, Bassett Healthcare, Cooperstown, New York, USA.
authors.forename: Anne C
authors.initials: AC
authors.lastname: Hermann
authors.forename: Anne N
authors.initials: AN
authors.lastname: Nafziger
authors.forename: Jennifer
authors.initials: J
authors.lastname: Victory
authors.forename: Robert
authors.initials: R
authors.lastname: Kulawy
authors.forename: Mario L
authors.initials: ML
authors.lastname: Rocci
authors.forename: Joseph S
authors.initials: JS
authors.lastname: Bertino
mesh_terms: D000284:Administration, Oral; D000287:Administration, Topical; D019540:Area Under Curve; D002214:Capsules / Q000008:administration & dosage* / Q000493:pharmacokinetics; D003358:Cosmetics / Q000737:chemistry / Q000493:pharmacokinetics; D018592:Cross-Over Studies; D004334:Drug Administration Schedule; D017277:Drug Approval; D005260:Female; D006261:Headache / Q000139:chemically induced; D006801:Humans; D008875:Middle Aged; D019547:Neck Pain / Q000139:chemically induced; D004366:Nonprescription Drugs / Q000008:administration & dosage / Q000737:chemistry / Q000493:pharmacokinetics*; D009824:Ointments / Q000008:administration & dosage / Q000493:pharmacokinetics; D010316:Particle Size; D017698:Postmenopause / Q000187:drug effects / Q000502:physiology; D011374:Progesterone / Q000008:administration & dosage* / Q000097:blood / Q000493:pharmacokinetics*
chemical_list: D002214:Capsules; D003358:Cosmetics; D004366:Nonprescription Drugs; D009824:Ointments; D011374:Progesterone