title: A Canadian multicentre prospective study on the effects of an oral contraceptive containing 3 mg drospirenone and 30 microg ethinyl oestradiol on somatic and psychological symptoms related to water retention and on body weight.
abstract: OBJECTIVE
  To evaluate the effects of an oral contraceptive containing 3 mg drospirenone (DRSP) and 30 microg ethinyl oestradiol (EE) on somatic and psychological symptoms related to water retention, and on body weight.
  
  
  METHODS
  This prospective study was performed in 26 centres in Canada over six treatment cycles. The first primary efficacy variable was the individual change in the water retention score of the Moos Menstrual Distress Questionnaire (MDQ) from baseline to the final examination in women with significant somatic symptoms related to water retention (n = 43). The second primary target variable was the change in body weight (n = 305).
  
  
  RESULTS
  Forty-three women met the criteria for the first primary target variable. In the premenstrual phase, the score decreased from 6.49 (SEM 0.45) at baseline to 3.19 (SEM 0.54) at the final examination (p = 0.0001). The data for the menstrual phase were 4.70 (SEM 0.30) at baseline and 2.35 (SEM 0.32) at the final examination (p < 0.0001). Baseline data from 299 women were assessed for the second primary target variable. Body weight did not change significantly, having increased only by 0.14 kg (SEM 0.13) at the final visit (p = 0.3082).
  
  
  CONCLUSIONS
  An oral contraceptive containing 3 mg DRSP and 30 microg EE significantly reduced the clinical symptoms of water retention. Body weight did not change.
authors.affiliation: Bayer Inc., Toronto, Ontario, Canada. jan.endrikat.b@bayer.com
authors.forename: Jan
authors.initials: J
authors.lastname: Endrikat
authors.forename: Mirella
authors.initials: M
authors.lastname: Sandri
authors.forename: Christoph
authors.initials: C
authors.lastname: Gerlinger
authors.forename: Alexander
authors.initials: A
authors.lastname: Rübig
authors.forename: Werner
authors.initials: W
authors.lastname: Schmidt
authors.forename: Michel
authors.initials: M
authors.lastname: Fortier
mesh_terms: D000328:Adult; D000736:Androstenes / Q000494:pharmacology* / Q000627:therapeutic use; D001834:Body Water / Q000187:drug effects* / Q000502:physiology; D001835:Body Weight / Q000187:drug effects* / Q000502:physiology; D002170:Canada; D003277:Contraceptives, Oral, Combined; D004487:Edema / Q000139:chemically induced* / Q000503:physiopathology / Q000523:psychology; D004997:Ethinyl Estradiol / Q000494:pharmacology* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D000451:Mineralocorticoid Receptor Antagonists / Q000494:pharmacology* / Q000627:therapeutic use; D011293:Premenstrual Syndrome / Q000139:chemically induced* / Q000175:diagnosis / Q000503:physiopathology / Q000523:psychology; D011446:Prospective Studies; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires
chemical_list: D000736:Androstenes; D003277:Contraceptives, Oral, Combined; D000451:Mineralocorticoid Receptor Antagonists; D004997:Ethinyl Estradiol; C035144:drospirenone