On November 28, the FDA approved synthetic conjugated estrogens-A 0.625 mg/g vaginal cream (SCE-A Vaginal Cream; Duramed Pharmaceuticals, Inc) for the treatment of moderate to severe vaginal dryness and moderate to severe dyspareunia, which are both symptoms of vulvar and vaginal atrophy due to menopause. SCE-A vaginal cream is administered intravaginally at a recommended dose of 1 g daily for 1 week, followed by a 1-g intravaginal dose twice a week.
SCE-A vaginal cream contains a blend of 9 plant-derived estrogenic substances in a nonliquefying base. According to a company news release, the product is designed to complement Duramed's existing line of therapies for postmenopausal symptoms.
The approval was based on data from a randomized, double-blind, placebo-controlled, multicenter study (n = 275), showing that SCE-A vaginal cream was significantly more effective than placebo for reduction of symptoms of vaginal dryness (P = .0016) and dyspareunia (P = .0002) during a 12-week period.
Other significant results included a mean increase in superficial cells (25.9% SCE-A vs 3.8% placebo), a mean decrease in parabasal cells (36.3% SCE-A vs 5.7% placebo), and a mean reduction in pH (1.47 SCE-A vs 0.30 placebo).
Common adverse effects include headache, vulvovaginal infection, upper respiratory tract infection, and hot flashes. Because the use of unopposed estrogens increases the risk for endometrial cancer, a progestin should be considered for postmenopausal women with a uterus who are treated with an estrogen. The addition of a progestin has been shown to reduce the risk for endometrial hyperplasia, a potential precursor to endometrial cancer, in women taking estrogen therapy.
Estrogen therapy also has been shown to increase the risk for gallbladder disease, and probable dementia in women older than 65 years of age. Women who are also receiving thyroid hormone replacement therapy should be monitored, and estrogen therapy should be discontinued in women who develop severe hypercalcemia, loss of vision, severe hypertriglyceridemia, or cholestatic jaundice.