Objective: To demonstrate the super

Objective: To demonstrate the superiority of estradiol valerate plus dienogest (E2V/DNG) over ethinylestradiol
plus levonorgestrel (EE/LNG) in reducing the number of days with dysmenorrheic pain amongwomen with primary
dysmenorrhea. Methods: In a phase IIIb trial conducted at 44 centers worldwide between April 2009 and
November 2010, otherwise healthy women aged 14 − 50 years requesting contraception were randomized to
daily oral administration of E2V/DNG (n=253) or EE/LNG (n=254) for three 28-day cycles. The primary efficacy
variablewas number of dayswith dysmenorrheic pain, the category ofwhich (none,mild,moderate, severe)
was self-assessed on a daily basis (irrespective of menstrual bleeding status) and recorded on diary cards. Notably,
the women documented their pain as they experienced it before taking any (permitted) rescue medication.
Results: Overall, 217 and 209 women receiving E2V/DNG and EE/LNG, respectively, completed the study. The
mean ± SD change from baseline in number of days with dysmenorrheic pain was –4.6 ± 4.6 days and
–4.2 ± 4.2 days for the E2V/DNG and EE/LNG groups, respectively (P = 0.34). Conclusion: Both E2V/DNG and
EE/LNG led to considerable relief of dysmenorrheic complaints among women with primary dysmenorrhea,
decreasing the number of days with dysmenorrheic pain from baseline to a similar extent.