title: Pituitary, ovarian and additional contraceptive effects of an estradiol-based combined oral contraceptive: results of a randomized, open-label study.
abstract: BACKGROUND
  The estrogen step-down/progestogen step-up 28-day estradiol valerate/dienogest (E(2)V/DNG) oral contraceptive effectively inhibits ovulation; however, limited data are available regarding its effects on estradiol (E2), progesterone, luteinizing hormone (LH) and follicle-stimulating hormone (FSH) or its additional extraovarian contraceptive effects.
  
  
  METHODS
  In this secondary analysis, 100 women received E(2)V 3 mg on days 1-2, E(2)V 2 mg/DNG 2 mg on days 3-7, E(2)V 2 mg/DNG 3 mg on days 8-24, E(2)V 1 mg on days 25-26 and placebo on days 27-28 for one treatment cycle. Measures included the presence/absence of cervical mucus; endometrial thickness; and serum E2, progesterone, and gonadotropin levels.
  
  
  RESULTS
  E2, progesterone, LH and FSH levels did not exhibit the typical ovulatory increase and remained relatively stable during the cycle. E(2)V/DNG reduced mean maximal endometrial thickness and proportion of women with visible cervical mucus. All parameters returned to pretreatment levels during the posttreatment cycle.
  
  
  CONCLUSIONS
  E(2)V/DNG provides extraovarian contraceptive effects (reducing endometrial thickness and cervical mucus production) in addition to inhibiting ovulation, assuring contraceptive efficacy.
authors.affiliation: Bayer HealthCare Pharmaceuticals, 13353 Berlin, Germany. jan.endrikat@bayer.com
authors.forename: Jan
authors.initials: J
authors.lastname: Endrikat
authors.forename: Susanne
authors.initials: S
authors.lastname: Parke
authors.forename: Dietmar
authors.initials: D
authors.lastname: Trummer
authors.forename: Marco
authors.initials: M
authors.lastname: Serrani
authors.forename: Ingrid
authors.initials: I
authors.lastname: Duijkers
authors.forename: Christine
authors.initials: C
authors.lastname: Klipping
mesh_terms: D000293:Adolescent; D000328:Adult; D002582:Cervix Mucus / Q000187:drug effects; D003277:Contraceptives, Oral, Combined / Q000493:pharmacokinetics*; D004717:Endometrium / Q000033:anatomy & histology / Q000187:drug effects; D004958:Estradiol / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000097:blood / Q000494:pharmacology; D005260:Female; D005640:Follicle Stimulating Hormone / Q000097:blood; D006801:Humans; D007986:Luteinizing Hormone / Q000097:blood; D009277:Nandrolone / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000494:pharmacology; D010053:Ovary / Q000187:drug effects*; D010060:Ovulation / Q000187:drug effects; D010902:Pituitary Gland / Q000187:drug effects*; D011374:Progesterone / Q000097:blood
chemical_list: D003277:Contraceptives, Oral, Combined; C023635:dienogest; D011374:Progesterone; D004958:Estradiol; D009277:Nandrolone; D007986:Luteinizing Hormone; D005640:Follicle Stimulating Hormone