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

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 s...

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Bibliographic Details
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
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Summary:	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.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	1369-7137 1473-0804
DOI:	10.1080/13697137.2023.2190507