Ultra-low-dose continuous combined estradiol and norethisterone acetate: improved bleeding profile in postmenopausal women

Sturdee, David W.; Archer, David F.; Rakov,; Lang, Eva

doi:10.1080/13697130701852390

Cited by 25 publications

(14 citation statements)

References 40 publications

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“…impact on mammographic density 132 and endometrium. 131 Efficacy of Estradiol 0.5 mg/ NETA 0.1 mg Compared with placebo, estradiol 0.5 mg/NETA 0.1 mg significantly reduced the number of moderate to severe hot flushes, beginning at treatment week 3 ( Figure 1A). 130 Symptom severity was also significantly reduced by week 3 compared with placebo, with further improvement by week 12, as well as a reduction in the hot flush weekly weighted score at all assessed time points (4, 8, 12 and 24 weeks).…”

Section: Clinical Benefits Of Estradiol 05 Mg/neta 01 Mgmentioning

confidence: 93%

“…130 The primary objective was to assess the mean change in the number of moderate to severe hot flushes per week and the mean change in severity score of moderate to severe hot flushes from baseline to week 8. 130 Secondary objectives included assessments of hot flush weekly weighted score, vaginal atrophy, sleep disturbances, bleeding pattern and Greene Climacteric Scale, 130,131 as well as an evaluation of several safety parameters, e.g. impact on mammographic density 132 and endometrium.…”

Section: Clinical Benefits Of Estradiol 05 Mg/neta 01 Mgmentioning

confidence: 99%

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Rationale for low-dose systemic hormone replacement therapy and review of estradiol 0.5 mg/NETA 0.1 mg

Johansen

Qvigstad

2008

Adv Therapy

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The menopausal transition is associated with several symptoms, for which both non-pharmacological and pharmacological measures are available to provide relief. However, present knowledge indicates that the former is not highly effective, and that the latter, in terms of systemic oestrogen and progestogen-based hormone replacement therapy (HRT), although being effective (e.g. on vasomotor symptoms, bleeding control, bone mineral density, vaginal atrophy and quality of life), can be associated with some caveats. Amongst these are an increased risk for coronary heart disease, breast cancer, venous thromboembolism and stroke. In recent years, literature has indicated a dose dependency for HRT on some of the caveats, hence authorities (Food and Drug Administration, and the European Medicines Agency) and menopause societies (International Menopause Society and North American Menopause Society) now recommend that women deemed in need of HRT should receive the lowest possible dose without compromising the effect of symptom relief. Estradiol 0.5 mg/norethisterone acetate (NETA) 0.1 mg, despite being a lower dose than conventional hormones, is a compound, among a few other low-dose options, that can be used in such therapy. As a first-line oral option, it has demonstrated its effectiveness (which seems comparable to other compounds), with high tolerability and, apparently, no safety concerns, in a 6-month study. Further long-term clinical trials and observational studies are mandatory in order to capture any potential harm as well as to elucidate this compound's full potential. Following a thorough literature search using PubMed and MEDLINE from the earliest publication dates through to January 2008, including results from various types of clinical trials and statements on HRT, we review the rationale for these recommendations. We also review the effects and safety of a novel 'ultra-low-dose' oral continuous combined HRT tablet, estradiol 0.5 mg/NETA 0.1 mg.

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Section: Clinical Benefits Of Estradiol 05 Mg/neta 01 Mgmentioning

confidence: 93%

Section: Clinical Benefits Of Estradiol 05 Mg/neta 01 Mgmentioning

confidence: 99%

Rationale for low-dose systemic hormone replacement therapy and review of estradiol 0.5 mg/NETA 0.1 mg

Johansen

Qvigstad

2008

Adv Therapy

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“…Im Allgemeinen werden 0,25-0,5 mg E 2 oral bzw. 14 µg E 2 transdermal als ultraniedrige Dosierungen bezeichnet [2,3,8,14,23,26,28,32,33]. Die International Menopause Society hat 2008 eine Terminologie für die verschiedenen Dosierungen veröffent-licht, die in .…”

Section: Ultraniedrige Dosierungunclassified

“…Auch die ultraniedrig dosierte Behandlung mit 0,5 mg E 2 +0,1 oder 0,25 mg NETA bzw. 2,5 mg Dydrogesteron zeigte eine niedrige Inzidenz uteriner Blutungen und Spottings [32,33].…”

Section: Introductionunclassified

Ultraniedrig dosierte Hormonersatztherapie

Wiegratz

2011

Gynäkologische Endokrinologie

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“…1 mg norethisterone acetate. Marketing authorization in the US, Canada, Israel and EU has been based on the CHOICE trial, which provided effi cacy and safety data for 24 weeks of treatment [5,6]. The Guideline on Clinical Investigation of Medicinal Products for Hormone Replacement Therapy of Oestrogen Defi ciency Symptoms in Postmenopausal Women (Committee for Medicinal Products for Human Use) suggests 52-week data be obtained for new ccHRT preparations.…”

Section: University Of G ö Teborg Sementioning

confidence: 99%

Abstracts of Posters

2014

Climacteric

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Background. Latin American women present a greater severity of climacteric symptoms than women from other parts of the world. Previous studies suggest that this could be due to either its Amerindian crossbreeding or the altitude in which a huge proportion of the LatinAmerican population lives. Objective. To answer this question climacteric symptoms between Peruvian women ("Hispanic-Mestizas" and "Quechuas"), living in similar altitude (around 3 000 MASL) were compared. Method. This is a cross sectional descriptive study of healthy women of 40 to 59 years of age living in native villages from el Cusco ' s District (Departamento de el Cusco, Peru). Using the MRS questionnaire climacteric symptoms were assessed in 771 Peruvian women; 395 "Hispanic-Mestizas" (Quechua-Spaniard breeding) and 376 pure "Quechuas". Results.The "Quechuas" compared with "Hispanic-Mestizas" have comparable similar age, but less: obesity, schooling years, cigarette smoking, use of hormonal therapy, diabetes and hypertension; and a greater: proportion of postmenopausal women and number of children. "Quechuas" showed a greater prevalence than "Hispanic-Mestizas" in ten of the eleven symptoms evaluated by the MRS scale, except for insomnia. The total MRS score was

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Ultra-low-dose continuous combined estradiol and norethisterone acetate: improved bleeding profile in postmenopausal women

Cited by 25 publications

References 40 publications

Rationale for low-dose systemic hormone replacement therapy and review of estradiol 0.5 mg/NETA 0.1 mg

Rationale for low-dose systemic hormone replacement therapy and review of estradiol 0.5 mg/NETA 0.1 mg

Ultraniedrig dosierte Hormonersatztherapie

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