What were the most common side effects associated with the use of ENJUVIA?
In a 12-week trial, 209 postmenopausal women with vasomotor symptoms were treated with ENJUVIA 0.3 mg, 0.625 mg, or 1.25 mg, or placebo. Adverse events that occurred at a rate ≥5% and greater than placebo, regardless of relationship to study drug, included headache, breast pain, nausea, pain, flu syndrome, bronchitis, rhinitis, sinusitis, abdominal pain, accidental injury, flatulence, vaginitis, dizziness, paresthesia, and dysmenorrhea.1 In a second 12-week clinical trial, 310 women with symptoms of vulvar and vaginal atrophy were treated (154 with ENJUVIA 0.3 mg and 156 with placebo). The only adverse event that occurred at a rate of >5% was headache, which occurred in 7 patients (4.55%) taking ENJUVIA and 12 patients (7.69%) taking placebo.
