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

• Published in: Climacteric : the journal of the International Menopause Society Vol. 26; no. 4; pp. 401 - 407
• Main Authors: Bonassi Machado, R., Pompei, L. de Melo, Nahas, E. A. P., Nahas-Neto, J., Costa-Paiva, L. da, Del Debbio, S. Y. O., Badalotti, M., Wender, M. C. O., Cruz, A. M.
• Format: Journal Article
• Language: English
• Published: England Taylor & Francis 01.08.2023; Taylor & Francis Ltd
• Subjects: Amenorrhea; Brazil; Double-Blind Method; efficacy; Estradiol; Estrogen Replacement Therapy; Female; hormone therapy; Humans; Middle Aged; Norethindrone - adverse effects; Norethindrone Acetate - pharmacology; Postmenopausal women; Postmenopause; safety; ultra-low-dose estradiol; Brazil; Postmenopausal women; hormone therapy; safety; efficacy; ultra-low-dose estradiol
• ISSN: 1369-7137; 1473-0804
• DOI: 10.1080/13697137.2023.2190507

This study aimed to evaluate the efficacy and safety of oral ultra-low-dose continuous combination of 17β-estradiol (17β-E2) and norethisterone acetate (NETA) in postmenopausal Brazilian women. Postmenopausal 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. A total of 118 women were included. The group treated with 0.5 mg 17β-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 17β-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. The combination of 0.5 mg 17β-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.