title: Comparative analysis of the effects of nomegestrol acetate/17 β-estradiol and drospirenone/ethinylestradiol on premenstrual and menstrual symptoms and dysmenorrhea.
abstract: OBJECTIVE
  To compare premenstrual and menstrual symptoms in healthy women using nomegestrol acetate/17β-estradiol (NOMAC/E2) and drospirenone/ethinylestradiol (DRSP/EE) via the Moos Menstrual Distress Questionnaire Form C (MDQ-C).
  
  
  METHODS
  Women completed the MDQ-C at baseline and after completion of cycles 1, 3, 6 and 13, for the premenstrual (four days before most recent flow) and menstrual (most recent flow) phases in two randomized controlled trials. Treatment effects of NOMAC/E2 and DRSP/EE on the t-scores of eight MDQ-C symptom domains from 3522 women were examined, and the effects of both treatments on the score for cramps from 1779 women with moderate to severe cramps at baseline. Longitudinal data analysis methods were applied in both analyses.
  
  
  RESULTS
  NOMAC/E2 users experienced a significant improvement in Pain, Water Retention, Negative Affect, Impaired Concentration and Behaviour Change domain scores in the menstrual phase compared with DRSP/EE users (p < 0.001 for all comparisons). However, Arousal (emotional and mental) scores worsened with NOMAC/E2 but not with DRSP/EE. Women with moderate to severe cramps experienced an improvement in the cramps score with NOMAC/E2 and DRSP/EE.
  
  
  CONCLUSIONS
  NOMAC/E2 was effective in reducing most premenstrual and menstrual symptoms, and was associated with significantly greater improvements in many MDQ-C domain scores compared with DRSP/EE. ( ClinicalTrials.gov: NCT00413062 and NCT00511199).
authors.affiliation: * MSD BV, Oss , The Netherlands.
authors.forename: Han
authors.initials: H
authors.lastname: Witjes
authors.forename: Mitchell D
authors.initials: MD
authors.lastname: Creinin
authors.forename: Inger
authors.initials: I
authors.lastname: Sundström-Poromaa
authors.forename: Allison
authors.initials: A
authors.lastname: Martin Nguyen
authors.forename: Tjeerd
authors.initials: T
authors.lastname: Korver
mesh_terms: D000328:Adult; D000736:Androstenes / Q000494:pharmacology*; D004412:Dysmenorrhea / Q000188:drug therapy*; D004958:Estradiol / Q000494:pharmacology*; D004997:Ethinyl Estradiol / Q000494:pharmacology*; D005260:Female; D006801:Humans; D008137:Longitudinal Studies; D008535:Megestrol / Q000494:pharmacology*; D008597:Menstrual Cycle / Q000187:drug effects*; D008875:Middle Aged; D009649:Norpregnadienes / Q000494:pharmacology*; D011293:Premenstrual Syndrome / Q000188:drug therapy*; D012102:Reproductive Control Agents / Q000494:pharmacology*; D011795:Surveys and Questionnaires; D055815:Young Adult
chemical_list: D000736:Androstenes; D009649:Norpregnadienes; D012102:Reproductive Control Agents; C534342:drospirenone and ethinyl estradiol combination; D004997:Ethinyl Estradiol; D004958:Estradiol; C038501:nomegestrol acetate; D008535:Megestrol
keywords: 17β-estradiol; DRSP/EE; MDQ; NOMAC/E2; combined oral contraceptive; drospirenone; ethinylestradiol; nomegestrol acetate