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.