A lower-dose estradiol vaginal cream than is currently available in the United States was an effective and well-tolerated treatment for dyspareunia in postmenopausal women, according to a recent phase 3, randomized, multicenter, double-blind, placebo-controlled trial. In the study, results of which were published in Menopause, 550 postmenopausal women with an average age of 58 years were randomized to a 0.003% vaginal cream containing 15 mcg estradiol or a placebo cream daily for 2 weeks as a priming dose followed by three times a week for 10 weeks. Use of the lower-dose estradiol cream (comparable in dose to low-dose vaginal estradiol tablets now available in the United States) was consistent with the recommendations of the Food and Drug Administration (FDA) and the North American Menopause Society to use low estrogen doses and vaginal delivery as appropriate to maximize benefits and minimize risks of hormone therapy.
Although over half of postmenopausal women have symptoms of vulvovaginal atrophy (VVA), it is typically underdiagnosed and undertreated, reported the study authors. All of the women in the current trial had signs and symptoms of VVA and reported dyspareunia as the most bothersome symptom of VVA. A self-administered 4-point scale (0=no dyspareunia to 3=severe dyspareunia) was used to assess severity of dyspareunia at screening and weeks 2, 4, 8, and 12 of the trial. Patients were also asked to self-assess vaginal/vulvar itching, dysuria, and vaginal dryness, and vaginal bleeding with intercourse on a 4-point scale (0=none, 3=severe), and investigators assessed extent of vaginal atrophy, pallor, dryness, friability, and petechiae on a 4-point scale (0=none, 3=severe) at screening and weeks 2, 4, 8, and 12 of the study. In addition, investigators measured vaginal cytology and pH at baseline and week 12.