Optimal tolerability of ultra-low-dose continuous combined 17beta-estradiol and norethisterone acetate: laboratory and safety results
| Autor: | G, Samsioe, J, Hruska, H, Zimmermann |
|---|---|
| Rok vydání: | 2009 |
| Předmět: |
Blood Glucose
medicine.medical_treatment Blood Pressure Pharmacology Placebo Placebos Double-Blind Method Sex Hormone-Binding Globulin medicine Humans Breast Insulin-Like Growth Factor I Adverse effect Hemostasis Estradiol business.industry Estrogen Replacement Therapy Obstetrics and Gynecology General Medicine 17beta estradiol Middle Aged medicine.disease Norethisterone acetate Lipids Menopause Postmenopause Norethindrone Acetate Tolerability Female Hormone therapy Uterine Hemorrhage Norethindrone business medicine.drug Mammography |
| Zdroj: | Climacteric : the journal of the International Menopause Society. 13(1) |
| ISSN: | 1473-0804 |
| Popis: | To evaluate the influence of two ultra-low doses of oral continuous combined hormone therapy and placebo on metabolic parameters, and to assess safety endpoints and overall tolerability in healthy postmenopausal women.In a subpopulation of the Clinical study on Hormone dose Optimisation In Climacteric symptoms Evaluation (CHOICE) trial, lipids and parameters of glucose metabolism and hemostasis were analyzed in Nordic women (n = 158) at baseline and after 12 and 24 weeks of treatment with 0.5 mg 17beta-estradiol (E2) + 0.25 mg norethisterone acetate (NETA), 0.5 mg E2 + 0.1 mg NETA or placebo. Adverse events occurring from the first trial-related activity, whether related or not related to the study medication, were recorded for the entire population (n = 575) of the trial. The seriousness, relationship to treatment and the reason for withdrawal were reported.Both ultra-low-dose combinations were neutral to changes in lipid and lipoprotein, hemostasis parameters and carbohydrate metabolism during the trial. The incidence of serious adverse events was only 1% in respective treatment groups. Adverse events were the reason for withdrawal in only 2% and 6% of women in the 0.5 mg E2 + 0.25 mg and 0.1 mg NETA groups, and in 8% in the placebo group. No weight gain or change in blood pressure was reported during the trial in any of the study groups.The treatments had neutral effects on metabolic parameters in the study population. Excellent tolerability of both ultra-low doses resulted in high completion rates. |
| Databáze: | OpenAIRE |
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