גינקולוגיה

SGI: Estrasorb (Estradiol) Significantly Reduces Hot Flashes in Postmenopausal Women

LOS ANGELES, CA — March 22, 2002 — Novavax Inc. today announced that the positive results of a randomized, double-blind, phase III, placebo-controlled clinical trial of Estrasorb (estradiol topical emulsion) in postmenopausal women were presented today at the Society for Gynecologic Investigation's (SGI) 49th Annual Scientific Meeting.

Patients using Estrasorb experienced an eighty-five percent reduction in the total number of hot flashes during the course of the trial. The study also found that approximately half the patients reported complete cessation of hot flashes during a seven-day period by week 10 of treatment, while fewer than 10 percent of patients in the placebo group noticed a similar improvement in symptoms.

The study, which enrolled 200 women who were naturally or surgically menopausal, consisted of a three-week screening period, a one-week placebo period, and a 12-week treatment period. A 3-gram dose (approximately 1/2 teaspoon) of Estrasorb with 7.5 mg estradiol (100 patients) or placebo emulsion (100 patients) was applied daily to each thigh and calf. Hot flash data was collected and recorded in a patient diary.

In the study, adverse effects with Estrasorb were similar to placebo and consistent with estrogens as a class. The most common adverse events included endometrial disorder, breast pain, vaginal hemorrhage and vaginal moniliasis.

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