Initial 17β-Estradiol dose for treating vasomotor symptoms1☆,
Section snippets
Materials and methods
A double-masked, randomized, placebo-controlled study was conducted in 15 centers in the United States. To properly establish the baseline level of vasomotor symptoms, subjects had a 2-week, no-therapy screening period, followed by a 12-week treatment period. Approval was obtained from the institutional review boards of the participating centers.
The study comprised 333 healthy menopausal women who signed informed consent forms. Each subject had an intact uterus, was 40–60 years old, and had at
Results
As shown in Table 1, demographic characteristics of women in this study appeared similar across treatment groups. The mean age of the women was 51 years, with a mean time of 3 years since their last menses. Approximately one third of the women (31%) had their last menses within 1 year before inclusion. The average number of moderate to severe hot flushes at baseline varied between 70 and 74 per week.
The changes in mean total of moderate to severe hot flushes per week reported in each group are
Discussion
Studies have documented the efficacy of 1 and 2 mg 17β-E2 for alleviating vasomotor symptoms. However, the efficacy of lower 17β-E2 doses for reducing moderate and severe symptoms in menopausal women has not been evaluated. The present study found that reduction in vasomotor symptoms with 17β-E2 dosage ranging from 0.25 to 2 mg followed a linear dose-response curve. Dosage of 1 and 2 mg rapidly alleviated the number and severity of hot flushes in highly symptomatic women, whereas lower doses of
References (8)
- et al.
Dose-response and withdrawal effects on climacteric symptoms after hormonal replacement therapy. A placebo-controlled therapeutic trial
Maturitas
(1983) - et al.
Low-dosage micronized 17β-estradiol prevents bone loss in postmenopausal women
Am J Obstet Gynecol
(1992) - et al.
Micronized 17β-estradiol for oral estrogen therapy in menopausal women
Obstet Gynecol
(1975) - et al.
Oral menopausal therapy using 17β-micronized estradiol
Obstet Gynecol
(1972)
Cited by (171)
Exposure to heavy metals and hormone levels in midlife women: The Study of Women's Health Across the Nation (SWAN)
2023, Environmental PollutionEffect of tibolone versus hormone replacement therapy on lower urinary tract symptoms and sexual function
2023, Journal of the Formosan Medical AssociationThe management of vasomotor symptoms of menopause (VMS) with menopausal hormone therapy (MHT)
2022, Current Opinion in Endocrine and Metabolic ResearchCitation Excerpt :Estrogen in various forms has been approved by the Federal Drug Administration of the USA (FDA) for the alleviation of menopause-associated VMS since 1942 [7]. MHT significantly reduces hot flush frequency and intensity compared to placebo in various randomized controlled trials (RCTs) and meta-analyses [8,9] in a dose-response fashion [10]. The addition of a progestogen as required in the presence of a uterus or testosterone when indicated for hypoactive sexual desire disorder does not alter the efficacy of estrogen in alleviating VMS.
Management of menopause in the breast cancer patient
2018, The Breast: Comprehensive Management of Benign and Malignant DiseasesA pragmatic approach to the management of menopause
2023, CMAJ. Canadian Medical Association Journal
- ☆
Statistical support was provided by Won-Chin Huang, PhD, from Novo Nordisk Pharmaceuticals Inc., Princeton, New Jersey.
Supported by grants to participating institutions by Novo Nordisk Pharmaceuticals Inc., Princeton, NJ, which markets micronized estradiol in Europe. Morris Notelovitz is a paid consultant and Nayan Nanavati and Joan-Carles Arce were employees at the time of research of Novo Nordisk Pharmaceuticals Inc.
- 1
The following investigators also participated in the trial: W. Abelove, A. L. Abt, A. B. Aven, G. Davila, S. F. Gordon, M. W. Heine, H. McQuarrie, L. S. Mihalov, M. Parr, C. Schwenker, and L. Speroff.