Effect of oral contraceptives containing estradiol and nomegestrol acetate or ethinyl-estradiol and chlormadinone acetate on primary dysmenorrhea.
OBJECTIVE
To study the three cycles effect on primary dysmenorrhea of the monophasic 24/4 estradiol/nomegestrol acetate (E2/NOMAC) and of the 21/7 ethinyl-estradiol/chlormadinone acetate (EE/CMA) oral contraceptive. The tolerability and the effect of both preparations on metabolism and health-related quality of life were also evaluated.


METHODS
Prospective observational cohort study.


METHODS
Tertiary gynecologic center for pelvic pain.


METHODS
Subjects with primary dysmenorrhea requiring an oral contraceptive, who spontaneously selected either E2/NOMAC (n = 20) or EE/CMA (n = 20).


METHODS
Visual Analogue Scale (VAS) score for dysmenorrhea, Short Form-36 questionnaire for health-related quality of life, lipoproteins and days of menstrual bleeding (withdrawal bleeding during oral contraceptive).


RESULTS
Mean age and body mass index (BMI) were similar between the two groups. The final analysis was performed on 34 women, 15 in E2/NOMAC and 19 in EE/CMA group. Compliance with treatment was significantly higher with EE/CMA (100%) than E2/NOMAC (75%) (p = 0.02). Both treatments significantly (p < 0.0001) reduced VAS of primary dysmenorrhea, similarly (E2/NOMAC by a mean of 74.7%, EE/CMA by a mean of 78.4%; p = 0.973). Only E2/NOMAC significantly increased SF-36 score (p = 0.001), both in physical (p = 0.001) and mental domains (p = 0.004). The mean number of days of menstrual bleeding was significantly reduced in E2/NOMAC group (from 4.86 ± 1.20 d to 2.64 ± 1.59 d, p = 0.0005 versus baseline, p = 0.007 versus EE/CMA group). BMI did not vary in either group. E2/NOMAC did not change lipoproteins and apoproteins while EE/CMA increased total cholesterol (p = 0.0114), HDL-cholesterol (p = 0.0008), triglycerides (p = 0.002), apoprotein-A1 (Apo-A1; p = 0.0006) and apopoprotein-B (Apo-B; p = 0.008), decreasing LDL/HDL ratio (p = 0.024).


CONCLUSIONS
Both oral contraceptives reduced similarly primary dysmenorrhea, with E2/NOMAC also reducing withdrawal bleedings and being neutral on lipid metabolism.
a Department of Obstetrics Gynecology and Pediatrics, Obstetrics and Gynecology Unit , Azienda Ospedaliero Universitaria Policlinico of Modena , Modena , Italy and.
Giovanni
G
Grandi
a Department of Obstetrics Gynecology and Pediatrics, Obstetrics and Gynecology Unit , Azienda Ospedaliero Universitaria Policlinico of Modena , Modena , Italy and.
Antonella
A
Napolitano
a Department of Obstetrics Gynecology and Pediatrics, Obstetrics and Gynecology Unit , Azienda Ospedaliero Universitaria Policlinico of Modena , Modena , Italy and.
Anjeza
A
Xholli
a Department of Obstetrics Gynecology and Pediatrics, Obstetrics and Gynecology Unit , Azienda Ospedaliero Universitaria Policlinico of Modena , Modena , Italy and.
Alessandra
A
Tirelli
b Department of Neurosciences and Reproductive Sciences , University of Naples Federico II , Naples , Italy.
Costantino
C
Di Carlo
a Department of Obstetrics Gynecology and Pediatrics, Obstetrics and Gynecology Unit , Azienda Ospedaliero Universitaria Policlinico of Modena , Modena , Italy and.
Angelo
A
Cagnacci
D000328:Adult; D002715:Chlormadinone Acetate / Q000627:therapeutic use*; D003278:Contraceptives, Oral, Hormonal / Q000627:therapeutic use*; D004338:Drug Combinations; D004412:Dysmenorrhea / Q000188:drug therapy*; D004958:Estradiol / Q000627:therapeutic use*; D004997:Ethinyl Estradiol / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008535:Megestrol / Q000627:therapeutic use*; D009649:Norpregnadienes / Q000627:therapeutic use*; D011446:Prospective Studies; D011788:Quality of Life; D016896:Treatment Outcome; D055815:Young Adult
D003278:Contraceptives, Oral, Hormonal; D004338:Drug Combinations; D009649:Norpregnadienes; D002715:Chlormadinone Acetate; D004997:Ethinyl Estradiol; D004958:Estradiol; C038501:nomegestrol acetate; D008535:Megestrol
Chlormadinone acetate; dysmenorrhea; estradiol; ethinyl-estradiol; metabolism; nomegestrol acetate; primary dysmenorrhea; quality of life