Objective: Data from a pivotal efficacy trial have been reanalyzed to explore the impact of age, uterine status, and ovarian status on the efficacy of estradiol gel 0.1% (Divigel) for the treatment of moderate to severe vasomotor symptoms associated with menopause.
Methods: Post hoc analyses were performed on data from a phase III clinical trial of estradiol gel 0.1%. These analyses explored the effects of age (<50, 50-59, ≥60 y) and uterine and ovarian status (intact or absent) on the change from baseline to week 12 in the frequency and severity of moderate to severe vasomotor symptoms. The effects of age, uterine status, and ovarian status were investigated for each individual dose (1.0, 0.5, and 0.25 g) of estradiol gel 0.1% (separately and pooled) compared with those of placebo.
Results: Treatment with any dose of estradiol gel 0.1% reduced both the frequency and severity of moderate to severe vasomotor symptoms from baseline regardless of age, uterine status, or ovarian status. Women 50 years or older, regardless of uterine or ovarian status, treated with estradiol gel 0.1% showed improvement in vasomotor symptoms compared with women given matched placebo. No interactions were detected between estradiol gel 0.1% treatment and age, uterine status, or ovarian status on vasomotor symptom frequency or severity.
Conclusions: Estradiol gel 0.1% treatment numerically decreased the frequency and severity of vasomotor symptoms in healthy, postmenopausal women independent of age, uterine status, or ovarian status. To our knowledge, these data are the first to directly explore the effects of age, hysterectomy, and oophorectomy on the efficacy of transdermal estrogen therapy.