title: Low-dose (0.3 mg) synthetic conjugated estrogens A is effective for managing atrophic vaginitis.
abstract: OBJECTIVE
  Estrogen or combined hormone (estrogen-progestin) therapy is highly efficacious for managing the signs and symptoms of urogenital atrophy. A low, effective estrogen dose may enhance patient acceptance and reduce side effects.
  
  
  METHODS
  In this randomized, double-blind, multicenter clinical trial, 71 healthy postmenopausal women with vaginal atrophy (Vaginal Maturation Index < or =55) received either low-dose synthetic conjugated estrogens, A tablets (Cenestin) (SCE-A), 0.3 mg once daily, or placebo for 16 weeks.
  
  
  RESULTS
  Treatment with SCE-A for 16 weeks resulted in a highly significant (P<0.0001) mean increase of 17.7 in the Vaginal Maturation Index compared to a mean increase of 4.1 with placebo treatment. A significant estrogenic improvement was detected as early as 4 weeks (mean increase 14.6). Superficial cells were significantly increased from 2.1% at baseline to 15.9% at week 16 with SCE-A, and parabasal cells were significantly reduced from 23.0% at baseline to 1.6% at week 16 (P<0.01 between treatments for both). Vaginal pH was significantly decreased from 6.2 at week -2 to 5.2 at week 16 with SCE-A compared to placebo (P<0.0001). There were no significant differences between treatment groups in the incidence of treatment-emergent side effects or other measures of safety, except for urinary tract infection, which occurred more frequently in the placebo group.
  
  
  CONCLUSIONS
  These results confirm the relatively rapid estrogenic effect and safety of a low-dose (0.3 mg/day) of slow-release SCE-A (Cenestin) in the treatment of vaginal atrophy in postmenopausal women.
authors.affiliation: Chicago Center for Clinical Research, 515 North State Street, Suite 2700, Chicago, IL 60610, USA. phylissmarx@radiantresearch.com
authors.forename: Phyllis
authors.initials: P
authors.lastname: Marx
authors.forename: George
authors.initials: G
authors.lastname: Schade
authors.forename: Shelby
authors.initials: S
authors.lastname: Wilbourn
authors.forename: Stephen
authors.initials: S
authors.lastname: Blank
authors.forename: Dean L
authors.initials: DL
authors.lastname: Moyer
authors.forename: Robert
authors.initials: R
authors.lastname: Nett
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001284:Atrophy / Q000188:drug therapy / Q000209:etiology; D045166:Estradiol Congeners; D004967:Estrogens / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004966:Estrogens, Conjugated (USP) / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D006863:Hydrogen-Ion Concentration; D008875:Middle Aged; D017698:Postmenopause / Q000187:drug effects*; D016896:Treatment Outcome; D014621:Vagina / Q000737:chemistry / Q000187:drug effects / Q000473:pathology*; D014627:Vaginitis / Q000188:drug therapy* / Q000473:pathology
chemical_list: D045166:Estradiol Congeners; D004967:Estrogens; D004966:Estrogens, Conjugated (USP); C509653:estrogens, conjugated synthetic A