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


CONCLUSIONS
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.
Department of Pediatrics, Obstetrics and Reproductive Medicine, University of Siena, Siena, Italy.
Felice
F
Petraglia
Global Clinical Development Women's HealthCare, Bayer HealthCare, Berlin, Germany.
Susanne
S
Parke
Global Medical Affairs Women's HealthCare, Bayer HealthCare, Berlin, Germany. Electronic address: marco.serrani@bayer.com.
Marco
M
Serrani
Global Clinical Statistics, Bayer HealthCare, Berlin, Germany.
Uwe
U
Mellinger
Department of Gynecology and Obstetrics, Evangelist Hospital Cologne-Weyertal, Cologne, Germany.
Thomas
T
Römer
D000293:Adolescent; D000328:Adult; D004311:Double-Blind Method; D004338:Drug Combinations; D004412:Dysmenorrhea / Q000188:drug therapy*; D004958:Estradiol / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004997:Ethinyl Estradiol / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D016912:Levonorgestrel / Q000627:therapeutic use*; D008875:Middle Aged; D009277:Nandrolone / Q000031:analogs & derivatives* / Q000627:therapeutic use; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
D004338:Drug Combinations; C454300:estradiol valerate-dienogest; C072593:ethinyl estradiol, levonorgestrel drug combination; D004997:Ethinyl Estradiol; D004958:Estradiol; D016912:Levonorgestrel; D009277:Nandrolone
Combined oral contraceptive; Estradiol valerate plus dienogest; Pelvic pain; Primary dysmenorrhea