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Human Reproduction, Vol. 14, No. 3, 606-610, March 1999
© 1999 European Society of Human Reproduction and Embryology

Pharmacokinetics of natural progesterone administered in the form of a vaginal tablet

T. Levy1, S. Gurevitch1, I. Bar-Hava1, J. Ashkenazi1, A. Magazanik2, R. Homburg1, R. Orvieto1 and Z. Ben-Rafael1,3

1 Departments of Obstetrics and Gynecology, and 2 Biochemistry Laboratory, Rabin Medical Center, Golda Campus, Petah Tikva and Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel

Our study was conducted to assess the pharmacokinetics of natural progesterone administered in the novel formula of an effervescent vaginal tablet. Fifty post-menopausal women, with a median age of 43.5 years (range 28–55), volunteered to participate in the research. All women discontinued their hormonal replacement therapy 1 month prior to the study. The pharmacokinetics of 50 and 100 mg of progesterone administered as a vaginal tablet were evaluated. After the initial administration of 50 mg or 100 mg, a mean serum Cmax of 20.43 ± 8.01 nmol/l and 31.61 ± 12.62 nmol/l (P < 0.0004) was reached at a Tmax of 6.1 ± 2.63 and 6.4 ± 3.35 h respectively. The terminal half-life was 13.18 ± 1.3 and 13.7 ± 1.05 h respectively. Continuous use of the 100-mg tablet resulted in a mean serum progesterone concentration of 26.08 ± 13.96 nmol/l and 21.42 ± 16.32 nmol/l after 14 and 30 days respectively. Women >40 years were found to have a significantly lower Tmax compared to younger women (P = 0.02). The continuous use of vaginal progesterone did not influence the hormonal, liver or lipid profiles evaluated. Only three (6%) women suffered from mild vaginal irritation. Natural progesterone given as a vaginal tablet is well tolerated, safe and an easily administered treatment. Even in a non-oestrogenized vagina the absorption was efficient and the 100 mg dosage resulted in adequate serum progesterone concentrations.

Key words: assisted reproductive technology/pharmacokinetics/progesterone/vaginal tablets

3 To whom correspondence should be addressed, at: Department of Obstetrics and Gynecology, Rabin Medical Center, Petah Tikva 49100, Israel


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