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• W2149239109 abstract "To determine the optimal daily dose of intranasal hormone therapy (HT) in order to achieve adequate endometrial protection. Multicentre, double-blind/double-dummy randomized controlled trial (Phase III) was conducted in 1741 women to compare a daily intranasal dose of 350 µg 17β-estradiol (E2) together with 50, 175 or 550 µg norethisterone (NET) with the oral administration of 2 mg E2 and 1 mg NET, over a period of 52 weeks. An endometrial biopsy was performed at the end of HT use. Most women (73–86%) had an ‘atrophic and/or inactive’ endometrium. Lower doses of NET were associated with a higher incidence of ‘proliferative’ endometrium. The incidence of vaginal bleeding decreased with time. During the last 4 months of the study, 88.1% of women using the highest dose of NET were in amenorrhoea when compared with 71.7% using the oral comparator (difference 16.5%; 95% confidence interval: 10.9–22.0%) ( P < 0.001). Premature discontinuation rates were in the range of 12–17% for the three nasal regimens and 22% for the oral comparator. HT using a fixed intranasal dose of 350 µg E2 combined with 550 µg NET is a safe regimen, in relation to 1 year endometrial safety. This regimen is associated with less vaginal bleeding when compared with an oral comparator using 2 mg E2 and 1 mg NET." @default.
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• W2149239109 date "2009-04-07" @default.
• W2149239109 modified "2023-10-18" @default.
• W2149239109 title "Endometrium protection and acceptability of nasally administered continuously combined hormone therapy: a multicentre, multinational, double-blind trial in post-menopausal women evaluating three regimens of 17 -estradiol and norethisterone when compared with an orally administered 17 -estradiol norethisterone regimen" @default.
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• W2149239109 doi "https://doi.org/10.1093/humrep/dep067" @default.
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