title: Lack of effect of isoflavonoids on the vagina and endometrium in postmenopausal women.
abstract: OBJECTIVE
  To determine the effects of soy-derived isoflavones on vaginal epithelium and the endometrium.
  
  
  METHODS
  Double-blind, randomized, placebo-controlled crossover trial.
  
  
  METHODS
  Outpatient clinic of a university hospital.
  
  
  METHODS
  Sixty-four postmenopausal women with a history of breast cancer.
  
  
  METHODS
  The women took (in a randomized order) 114 mg of isolated isoflavonoids or placebo in tablets daily for 3 months; the treatment regimens were crossed over after a 2-month washout period. The subjects were studied before and on the last day of each treatment period.
  
  
  METHODS
  Vaginal dryness, maturation index (MI) of vaginal epithelium, endometrial thickness, histology, and expression of estrogen (E) and progesterone (P) receptors and the proliferation marker Ki-67 in the endometrium.
  
  
  RESULTS
  Isolated isoflavones did not relieve vaginal dryness. Maturation index values remained unchanged during the isoflavone regimen, but decreased during the placebo regimen. No changes were found in any of the variables measured in the endometrium.
  
  
  CONCLUSIONS
  Daily administration of 114 mg of isolated isoflavones for 3 months had no effect on the subjective perception of vaginal dryness or on objective findings in the vagina or endometrium. This implies safety with regard to the endometrium.
authors.affiliation: Department of Obstetrics and Gynecology, Helsinki University Central Hospital, Helsinki, Finland. eini.nikander@pp.fimnet.fi
authors.forename: Eini
authors.initials: E
authors.lastname: Nikander
authors.forename: Eeva-Marja
authors.initials: EM
authors.lastname: Rutanen
authors.forename: Pekka
authors.initials: P
authors.lastname: Nieminen
authors.forename: Torsten
authors.initials: T
authors.lastname: Wahlström
authors.forename: Olavi
authors.initials: O
authors.lastname: Ylikorkala
authors.forename: Aila
authors.initials: A
authors.lastname: Tiitinen
mesh_terms: D000328:Adult; D000368:Aged; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004717:Endometrium / Q000187:drug effects* / Q000473:pathology; D005260:Female; D006801:Humans; D007529:Isoflavones / Q000494:pharmacology*; D019394:Ki-67 Antigen / Q000032:analysis; D008875:Middle Aged; D017698:Postmenopause; D011960:Receptors, Estrogen / Q000032:analysis; D011980:Receptors, Progesterone / Q000032:analysis; D014621:Vagina / Q000187:drug effects*
chemical_list: D007529:Isoflavones; D019394:Ki-67 Antigen; D011960:Receptors, Estrogen; D011980:Receptors, Progesterone