Efficacy and Safety of a Combined Oral Contraceptive Containing Estradiol Valerate/Dienogest: Results from a Clinical Study Conducted in North America

Anita L. Nelson, Susanne Parke, Uwe Mellinger, Edio Zampaglione, Anja Schmidt
In: Journal of Women's Health · 2013 · vol. 23(3) , pp. 204–210 · doi:10.1089/jwh.2013.4320 · PMID:24279594 · W1918024871
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This study found that a combined oral contraceptive containing estradiol valerate and dienogest was effective in preventing pregnancy for women aged 18-35 in North America, with 5 pregnancies in the first year.

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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.

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