Hermann Anne C, Nafziger Anne N, Victory Jennifer, Kulawy Robert, Rocci Mario L, Bertino Joseph S
Department of Medicine, Bassett Healthcare, Cooperstown, New York, USA.
J Clin Pharmacol. 2005 Jun;45(6):614-9. doi: 10.1177/0091270005276621.
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.
黄体酮产品有处方形式，也有作为“化妆品”用途销售的非处方（OTC）外用制剂。在一项随机研究设计中，作者比较了按每种产品推荐的标记日剂量使用非处方黄体酮乳膏与美国食品药品监督管理局批准的口服制剂的药物暴露情况。12名健康的绝经后女性，每天服用一次200毫克口服黄体酮胶囊，共12天，或每天两次涂抹40毫克黄体酮乳膏，共12天。在稳态时（每个阶段的第12天），采集24小时（口服黄体酮）或12小时（外用黄体酮）的全血样本，并检测总黄体酮浓度。比较乳膏和口服胶囊，在剂量标准化的24小时黄体酮暴露方面未发现显著差异（中位AUC(0 - 24)分别为12.5 ng·h/mL和10.5 ng·h/mL；P = 0.81）。鉴于长期使用黄体酮存在潜在风险，作者质疑外用黄体酮产品是否应作为非处方药提供。
