| Participants |
Menopausal status: peri‐ and post‐menopausal
Age: mean 54.12 ± 4.14 years (mean ± SD) (range 40 to 60 years)
Location: USA
Ethnicity: Race (n, %) in placebo, 0.25 mg E2, 0.5 mg E2, 1.0 mg E2, 2.0 mg E2 respectively:
White ‐ 60 (91%), 62 (91%), 61 (95%), 57 (85%), 62 (91%)
Black ‐ 3 (5%), 3 (4%), 2 (3%), 5 (7%), 1 (1%)
Hispanic ‐ 1 (2%), 2 (3%), 1 (2%), 4 (6%), 3 (4%)
Asian/Pacific ‐ 2 (3%), 0 (0%), 0 (0%), 1 (1%), 2 (3%)
Other ‐ 0 (0%), 1 (1%), 0 (0%), 0 (0%), 0 (0%)
Source: study population was obtained from the investigators´ sites or through local advertising (i.e. a mixture of clinical and general population)
Inclusion Criteria: menopause symptoms persisting for more than 6 months, healthy menopausal women with an intact uterus, 40‐60 years old, at least 56 moderate‐severe hot flushes/week, at least 6 months amenorrhoea, E2 levels <= 20pg/mL, FSH >= 50 IU/L
Exclusion Criteria: history of endometrial hyperplasia, abnormal bleeding of unknown origin, endometrial thickness at least 5mm, history of estrogen‐dependent tumours, gallbladder, liver kidney or endocrine diseases except controlled thyroid disease, venous thromboembolism, cerebrovascular accidents, myocardial infarction or ischaemic heart disease, history of severe headache or migraines, high blood pressure, alcohol or drug abuse, smoking > 15 cigarettes/day, weight increased more than 20% over ideal body weight, use of steroid hormones/drugs known to influence estrogen metabolism & use of HRT within 2 months prior to randomisation
Confirmation of Ovarian Failure: at least 6 months amenorrhoea, E2 levels <= 20pg/mL, FSH >= 50 IU/L
Baseline Equality: matched for age, time of amenorrhoea, weight, baseline hot flush symptoms
Baseline Symptoms: At least 56, with 72 ± 21 (mean ± SD) moderate‐severe hot flushes/week & mean hot flush weekly weighted score 183 ± 61(mean ± SD). |
