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Estradiol valerate plus dienogest versus ethinylestradiol plus levonorgestrel for the treatment of primary dysmenorrhea
Author(s) -
Petraglia Felice,
Parke Susanne,
Serrani Marco,
Mellinger Uwe,
Römer Thomas
Publication year - 2014
Publication title -
international journal of gynecology and obstetrics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.895
H-Index - 97
eISSN - 1879-3479
pISSN - 0020-7292
DOI - 10.1016/j.ijgo.2013.11.017
Subject(s) - dienogest , medicine , levonorgestrel , estradiol valerate , ethinylestradiol , gynecology , population , estrogen , family planning , endometriosis , research methodology , environmental health
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‐day cycles. 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