Safety and efficacy of micronized estradiol vaginal cream.

Fifty-four postmenopausal patients with atrophic vaginitis satisfactorily completed one to two months' therapy with daily intravaginal application of 0.2 mg of 17 beta-estradiol in a cream base. No significant alterations were noted in the hematologic biochemical, and urine analyses. A number of response criteria showed significant improvement (P less than .01), including the severity rating for atrophic vaginitis, the maturation index of vaginal cells, the frequency and severity of hot flashes, the presence of vaginal dryness and itching, dyspareunia, skin flushing, and the severity of sweating episodes. The incidence of side effects was low and included breast tenderness and abdominal cramping.