Estradiol valerate plus dienogest versus ethinylestradiol plus levonorgestrel for the treatment of primary dysmenorrhea

Felice Petraglia, Susanne Parke, Marco Serrani, Uwe Mellinger, Thomas Römer
In: International Journal of Gynecology & Obstetrics · 2014 · vol. 125(3) , pp. 270–274 · doi:10.1016/j.ijgo.2013.11.017 · PMID:24713413 · W2028726689
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Estradiol valerate/dienogest and ethinylestradiol/levonorgestrel similarly reduced days with dysmenorrheic pain in women with primary dysmenorrhea.

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Abstract

OBJECTIVE: To demonstrate the superiority of estradiol valerate plus dienogest (E(2)V/DNG) over ethinylestradiol plus levonorgestrel (EE/LNG) in reducing the number of days with dysmenorrheic pain among women 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 E(2)V/DNG (n = 253) or EE/LNG (n = 254) for three 28-daycycles. The primary efficacy variable was number of days with dysmenorrheic pain, the category of which (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 E(2)V/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 E(2)V/DNG and EE/LNG groups, respectively (P = 0.34). CONCLUSION: Both E(2)V/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. ClinicalTrials.gov:NCT00909857.

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dysmenorrhea

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