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
Anne C
AC
Department of Medicine, Bassett Healthcare, Cooperstown, New York, USA.
Nafziger
Anne N
AN
Victory
Jennifer
J
Kulawy
Robert
R
Rocci
Mario L
ML
Bertino
Joseph S
JS
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*
D002214:Capsules; D003358:Cosmetics; D004366:Nonprescription Drugs; D009824:Ointments; D011374:Progesterone