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

Anita L. Nelson, Susanne Parke, Dagmar Makalová, Marco Serrani, Santiago Palacios, Uwe Mellinger
In: The European Journal of Contraception & Reproductive Health Care · 2013 · vol. 18(4) , pp. 264–273 · doi:10.3109/13625187.2013.780202 · PMID:23651474 · W2035273725
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This pooled analysis of three trials found that the estradiol valerate/dienogest combined oral contraceptive demonstrated a Pearl Index of 0.79, indicating reliable contraceptive efficacy in women aged 18 to 50 years.

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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.

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