title: Effective treatment of vaginal atrophy with isoflavone vaginal gel.
abstract: OBJECTIVE
  To assess efficacy and tolerability of a isoflavone (Glycine max L. Merr.) vaginal gel to the treatment of vaginal atrophy in postmenopausal women.
  
  
  METHODS
  The double-blind, randomized, placebo-controlled, clinical trial. Ninety women were treated for 12 weeks with isoflavone vaginal gel 4% (1g/day) and a placebo gel and conjugated equine estrogen cream (0.3mg/day). After 4 and 12 weeks, the vaginal atrophy symptoms were classified at none, mild, moderate and severe and the vaginal cytology were taken to determine the maturation value. The endometrial safety (by transvaginal ultrasonography) was evaluated through at screening and the end of the trial.
  
  
  RESULTS
  Isoflavone vaginal gel appears to be effective for relief of vaginal dryness and dyspareunia symptoms and an increase in the intermediate and superficial cells was noted. These results were similar to the effects with use of conjugated equine estrogens and superior to placebo gel. No changes in endometrial thickness, sera FSH and estradiol levels were observed at study endpoint.
  
  
  CONCLUSIONS
  Glycine max (L.) Merr. at 4% vaginal gel on a daily basis in postmenopausal women led to improvements in vaginal atrophy symptoms and a significant increase in cell maturation values. Isoflavones proved good treatment options for relief of vulvovaginal symptoms especially in women who do not wish to use hormonal therapy or have contra-indications for this treatment.
authors: Department of Gynecology and Obstetrics, Santa Casa of Sao Paulo Medical School, Sao Paulo, Brazil.
authors: Sonia M Rolim Rosa
authors: SM
authors: Lima
authors: Department of Gynecology and Obstetrics, Santa Casa of Sao Paulo Medical School, Sao Paulo, Brazil.
authors: Silvia Saito
authors: SS
authors: Yamada
authors: Department of Gynecology and Obstetrics, Santa Casa of Sao Paulo Medical School, Sao Paulo, Brazil; Department of Gynecology and Obstetrics, Vale do Sapucaí University, Pouso Alegre, Minas Gerais, Brazil. Electronic address: benefabiano@uol.com.br.
authors: Benedito Fabiano
authors: BF
authors: Reis
authors: Department of Gynecology and Obstetrics, Santa Casa of Sao Paulo Medical School, Sao Paulo, Brazil.
authors: Sostenes
authors: S
authors: Postigo
authors: Department of Pathology, Santa Casa of Sao Paulo Medical School, Sao Paulo, Brazil.
authors: Maria Antonieta L
authors: MA
authors: Galvão da Silva
authors: Department of Gynecology and Obstetrics, Santa Casa of Sao Paulo Medical School, Sao Paulo, Brazil.
authors: Tsutomu
authors: T
authors: Aoki
mesh_terms: D001284:Atrophy; D004311:Double-Blind Method; D004414:Dyspareunia / Q000188:drug therapy; D004717:Endometrium / Q000187:drug effects; D004958:Estradiol / Q000097:blood; D015914:Estrogen Replacement Therapy / Q000379:methods; D004966:Estrogens, Conjugated (USP) / Q000627:therapeutic use; D005260:Female; D005640:Follicle Stimulating Hormone / Q000097:blood; D005500:Follow-Up Studies; D006801:Humans; D007529:Isoflavones / Q000627:therapeutic use*; D008875:Middle Aged; D010919:Placebos; D017698:Postmenopause / Q000187:drug effects; D013025:Glycine max; D016896:Treatment Outcome; D014463:Ultrasonography; D014621:Vagina / Q000000981:diagnostic imaging / Q000187:drug effects* / Q000473:pathology; D014622:Vaginal Creams, Foams, and Jellies / Q000627:therapeutic use; D014623:Vaginal Diseases / Q000188:drug therapy
chemical_list: D004966:Estrogens, Conjugated (USP); D007529:Isoflavones; D010919:Placebos; D014622:Vaginal Creams, Foams, and Jellies; D004958:Estradiol; D005640:Follicle Stimulating Hormone
keywords: Conjugated equine estrogen; Endometrium; Glycine max (L.) Merr.; Hormone replacement therapy; Isoflavone; Vagina