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

AbstractOBJECTIVE:
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.
AuthorsFelice Petraglia, Susanne Parke, Marco Serrani, Uwe Mellinger, Thomas Römer
JournalInternational journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics (Int J Gynaecol Obstet) Vol. 125 Issue 3 Pg. 270-4 (Jun 2014) ISSN: 1879-3479 [Electronic] Ireland
PMID24713413 (Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
CopyrightCopyright © 2014 International Federation of Gynecology and Obstetrics. All rights reserved.
Chemical References
  • estradiol valerate-dienogest
  • ethinyl estradiol, levonorgestrel drug combination
  • Ethinyl Estradiol
  • Estradiol
  • Levonorgestrel
  • Nandrolone
Topics
  • Adolescent
  • Adult
  • Double-Blind Method
  • Dysmenorrhea (drug therapy)
  • Estradiol (analogs & derivatives, therapeutic use)
  • Ethinyl Estradiol (therapeutic use)
  • Female
  • Humans
  • Levonorgestrel (therapeutic use)
  • Middle Aged
  • Nandrolone (analogs & derivatives, therapeutic use)
  • Time Factors
  • Treatment Outcome
  • Young Adult

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