Efficacy and safety of ultra-low-dose estradiol and norethisterone in postmenopausal Brazilian women

ObjectiveThis study aimed to evaluate the efficacy and safety of oral ultra-low-dose continuous combination of 17 beta-estradiol (17 beta-E2) and norethisterone acetate (NETA) in postmenopausal Brazilian women.MethodsPostmenopausal women (age 45-60 years) with amenorrhea >12 months and intact uterus, with moderate to severe vasomotor symptoms, were included. The vasomotor symptoms and endometrial bleeding were evaluated by a daily diary for 24 weeks, and the women were assessed at baseline and endpoint.ResultsA total of 118 women were included. The group treated with 0.5 mg 17 beta-E2/0.1 mg NETA (n = 58) showed a percentage reduction of 77.1% in the frequency of vasomotor symptoms versus 49.9% in the placebo group (n = 60) (p = 0.0001). The severity score showed a reduction in the treatment group when compared to the placebo (p < 0.0001). The adverse events were comparable between the groups; however, in the 0.5 mg 17 beta-E2/0.1 mg NETA group there were more complaints of vaginal bleeding; despite that, in most cycles in both treatment groups, more than 80% of women experienced amenorrhea.ConclusionsThe combination of 0.5 mg 17 beta-E2/0.1 mg NETA in a continuous combination regimen was shown to be effective in reducing the frequency and severity of vasomotor symptoms in Brazilian postmenopausal women.

Automated summary

This study evaluated the efficacy and safety of oral ultra-low-dose continuous combination of 17 beta-estradiol (17β-E2) and norethisterone acetate (NETA) in postmenopausal Brazilian women. The group treated with 0.5 mg 17β-E2/0.1 mg NETA showed a significant reduction in the frequency and severity of vasomotor symptoms compared to the placebo group. Adverse events were comparable between the groups, but there were more complaints of vaginal bleeding in the 0.5 mg 17β-E2/0.1 mg NETA group.