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Merck

Low-dose ethinylestradiol/levonorgestrel.

Drugs (2005-11-04)
Toni M Dando, Monique P Curran
ABSTRACT

Low-dose ethinylestradiol/levonorgestrel 20 microg/100 microg is a combined oral contraceptive that prevents pregnancy primarily by inhibiting ovulation. The Pearl index (pregnancies per 100 woman-years of use) with ethinylestradiol/levonorgestrel 20 microg/100 microg was 0.88 and the cumulative pregnancy rate was 1.9% at the end of a 3-year open-label trial (1708 women with 26 554 evaluable cycles). The contraceptive efficacy of ethinylestradiol/levonorgestrel 20 microg/100 microg was similar to that of other low-dose combined oral contraceptives containing ethinylestradiol 20 or 35 microg in a 6-cycle trial (463 evaluable women). Ethinylestradiol/levonorgestrel 20 microg/100 microg is well tolerated; adverse events were those commonly associated with combined oral contraceptives. Headache and metrorrhagia (2% of women) were the most common adverse events leading to treatment discontinuation in the 3-year trial. Cycle control in open-label trials in women receiving up to 36 cycles of ethinylestradiol/levonorgestrel 20 microg/100 microg was generally good, with the incidence of intermenstrual bleeding being highest during the first few cycles of use and decreasing thereafter.

MATERIALS
Product Number
Brand
Product Description

Ethinylestradiol for system suitability, European Pharmacopoeia (EP) Reference Standard
Ethinylestradiol, European Pharmacopoeia (EP) Reference Standard
Supelco
Ethinyl Estradiol, Pharmaceutical Secondary Standard; Certified Reference Material
USP
Ethinyl estradiol, United States Pharmacopeia (USP) Reference Standard
Sigma-Aldrich
17α-Ethynylestradiol, ≥98%
Supelco
17α-Ethynylestradiol solution, 1.0 mg/mL in methanol, ampule of 1 mL, certified reference material, Cerilliant®