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

@article{Hermann2005OvertheCounterPC,
  title={Over‐the‐Counter Progesterone Cream Produces Significant Drug Exposure Compared to a Food and Drug Administration‐Approved Oral Progesterone Product},
  author={Anne C Hermann and Anne N. Nafziger and Jennifer M Victory and Robert Kulawy and Mario L. Rocci and Joseph S. Bertino},
  journal={The Journal of Clinical Pharmacology},
  year={2005},
  volume={45}
}
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… Expand
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TLDR
Data show that significant serum progesterone levels can be achieved by oral administration, and can be significantly improved by the physical characteristics of the progester one and the vehicle used with oral administration. Expand
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Absorption of micronized P was enhanced twofold in the presence of food and both absorption and elimination were dose-independent, dose proportionality being confirmed. Expand
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Crinone (progesterone gel) given vaginally results in greater bioavailability with less relative variability than oral progesterone, thus providing more reliable delivery of progester one, compared with oral progestersone. Expand
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Findings are in general agreement with previous reports showing that luteal phase serum P concentrations can be reached easily with non-parenteral modes of administering micronized P and that oral P administration could become an attractive alternative to the currently used oral mode of administering synthetic progestins. Expand
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TLDR
Findings are in general agreement with previous reports showing that luteal phase serum P concentrations can be reached easily with non-parenteral modes of administering micronized P and that oral P administration could become an attractive alternative to the currently used oral mode of administering synthetic progestins. Expand
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