Low-dose (0.3 mg) synthetic conjugated estrogens A is effective for managing atrophic vaginitis.
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.
Marx
Phyllis
P
Chicago Center for Clinical Research, 515 North State Street, Suite 2700, Chicago, IL 60610, USA. phylissmarx@radiantresearch.com
Schade
George
G
Wilbourn
Shelby
S
Blank
Stephen
S
Moyer
Dean L
DL
Nett
Robert
R
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
D045166:Estradiol Congeners; D004967:Estrogens; D004966:Estrogens, Conjugated (USP); C509653:estrogens, conjugated synthetic A