Pharmacokinetic comparison of two triphasic oral contraceptive formulations containing levonorgestrel and ethinylestradiol

Contraception
F Z StanczykT B Woutersz

Abstract

The pharmacokinetics of levonorgestrel (LNG) and ethinylestradiol (EE2) were determined in 24 women (aged 21 to 35 years), following the administration of a single tablet from the second phase of two different triphasic preparations (Triphasil and Trinordiol. Each tablet contained 0.075 mg of LNG and 0.040 mg of EE2. The data were compared to the pharmacokinetics of LNG and EE2 obtained following the oral administration of a hydroalcoholic solution (standard) containing the same steroids and dose. The study consisted of a randomized design in which the three formulations were administered to each of the 24 subjects in a three-period crossover pattern. Blood samples were taken at frequent intervals after dosing. Serum levels of LNG and EE2 were measured by specific radioimmunoassays. The results show that both LNG and EE2 in the Triphasil and Trinordiol tablets are bioequivalent with respect to rate and extent of absorption. Furthermore, LNG, but not EE2, in both tablet formulations was bioequivalent to the solution dose. The serum concentration-time profiles for the three formulations showed that the range of mean peak levels was 2.3-2.8 ng/ml for LNG and 116-159 pg/ml for EE2. These levels were achieved within 2 hours in the m...Continue Reading

References

Aug 1, 1978·The Journal of Pharmacy and Pharmacology·D J Cutler
Jul 1, 1985·Contraception·J Newburger, J W Goldzieher
Mar 1, 1983·Clinical Pharmacokinetics·M L OrmeA M Breckenridge
Jul 1, 1983·Journal of Steroid Biochemistry·K Fotherby
Oct 1, 1982·Journal of Pharmacokinetics and Biopharmaceutics·K K Chan, M Gibaldi

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Citations

Dec 12, 2003·Steroids·Frank Z Stanczyk
Mar 21, 2001·Contraception·T SarkolaC J Eriksson
Dec 1, 1990·American Journal of Obstetrics and Gynecology·C Jung-Hoffman, H Kuhl
Sep 6, 2015·Fertility and Sterility·Manuela Menezes MáximoOmero Benedicto Poli-Neto
Mar 28, 2016·The Journal of the American Dental Association·Diane R Bienek, James J Filliben

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