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• W1918024871 abstract "Background: This study investigated the efficacy and safety of a combined oral contraceptive (COC) containing estradiol valerate/dienogest (E2V/DNG). Methods: This was a multicenter, noncomparative, 13-cycle (extended to 28 cycles) study conducted in the United States and Canada. Contraceptive efficacy was calculated as a Pearl Index for 13 cycles, based on all on-treatment pregnancies; bleeding patterns were calculated based on bleeding and spotting information recorded daily in diary cards. Safety events during a 16-month extension study were added to the 1-year data. Results: In total, 499 women, aged 18–35 years, were enrolled, and 490 of them were included in the full analysis set for contraceptive efficacy. Five pregnancies occurred in the first year (unadjusted Pearl Index=1.64). In cycles 1–12, an average 23.5% of women had absent scheduled (withdrawal) bleeding. Among women with scheduled (withdrawal) bleeding, bleeding started after a median of 2 days after intake of the last DNG-containing pill. For safety, data included from 147 women followed over an additional 16 months were added to the original 13-cycle data set. Treatment-related adverse events (AEs) occurred in 51.8% of women; 14.9% discontinued because of AEs over the entire 28-month study period. Conclusion: A COC with E2V and DNG was shown to provide effective contraception in women aged 18–35 years in North America." @default.
• W1918024871 created "2016-06-24" @default.
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• W1918024871 date "2014-03-01" @default.
• W1918024871 modified "2023-09-23" @default.
• W1918024871 title "Efficacy and Safety of a Combined Oral Contraceptive Containing Estradiol Valerate/Dienogest: Results from a Clinical Study Conducted in North America" @default.
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• W1918024871 doi "https://doi.org/10.1089/jwh.2013.4320" @default.
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