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Efficacy and bleeding profile of a combined oral contraceptive containing oestradiol valerate/dienogest: A pooled analysis of three studies conducted in North America and Europe

Abstract Objective To summarise all clinical data on the contraceptive efficacy and bleeding profile associated with an oestradiol valerate (E2V) and dienogest (DNG) [E2V/DNG] combined oral contraceptive (COC) derived from Phase III trials. Methods Pooled analysis of three large-scale multicentre trials conducted in healthy women who received oral E2V/DNG for 7 to 28 cycles (28-day cycles). Results A total of 2266 women were included in this analysis. Overall, 19 pregnancies occurred over 13 cycles during 880,950 days of relevant exposure (Pearl Index [PI] of 0.79; upper limit of the two-sided 95% confidence interval [CI]: 1.23). Ten pregnancies attributed to method failure came about during 871,091 days of relevant exposure (adjusted PI of 0.42; upper limit of the two-sided 95% CI: 0.77). In women aged 18 to 35 years (n = 1687), the corresponding PI and adjusted PI were 1.01 (upper limit of the two-sided 95% CI: 1.59) and 0.51 (upper limit of the two-sided 95% CI: 0.97), respectively. In the first 13 cycles of treatment, 76 to 81% of women experienced scheduled withdrawal bleeding, and 13 to 23% experienced intracyclic bleeding. Conclusions E2V/DNG provides reliable contraceptive efficacy in women aged 18 to 50 years.