Efficacy and safety of a combined oral contraceptive containing estradiol valerate/dienogest: results from a clinical study conducted in North America

Anita L. Nelson, Anita Nelson, Susanne Parke, Uwe Mellinger, Edio Zampaglione, Anja Schmidt
Journal of women's health (2002) · 2013 · vol. 23(3) , pp. 204–210 · doi:10.1089/jwh.2013.4320 · PMID:24279594 · W1918024871
Non-randomised trial OA: closed CC0 ⤵ 10 in-corpus citations
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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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MeSH descriptors

Contraception Contraceptives, Oral, Combined Estradiol Nandrolone Ovulation Inhibition Adolescent Adult Canada Contraception Contraceptives, Oral, Combined Contraceptives, Oral, Combined Drug Administration Schedule Drug Combinations Estradiol Estradiol Estradiol Female Humans Menstrual Cycle Menstrual Cycle

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