Effects of the combined hormonal replacement drug estradiol valerate/levonorgestrel on climacteric complaints, endometrium and lipid profile of peri- and postmenopausal women.

The effects of the combined hormone replacement (HRT) drug estradiol valerate/levonorgestrel (Klimonorm) on climacteric complaints, endometrial status and lipid profile was studied in 100 peri- and postmenopausal women aged between 41 and 57 years. The duration of therapy was 6 months. The following parameters were investigated: Kuppermann index, endometrial thickness, duration of bleeding, arterial blood pressure, body weight and serum lipids and lipoproteins (total cholesterol TC, LDL cholesterol, HDL cholesterol, and triglycerides [TG]). A separate analysis was made for 27 patients who had abnormal lipid status before treatment. Total cholesterol above 6.0 mmol/l and/or LDL of more than 3.5 mmol/l was considered abnormal and those patients were labeled as "high risk". The results showed a statistically significant reduction in the severity of climacteric symptoms (Kupperman index). A large decrease in the score was observed during the first 3 months of treatment (from 27.9 at the start to mean values of 9.3, p < 0.001). A further slight decrease of the score to 4.0 (p < 0.001) was seen after 6 months of treatment. Endometrial thickness did not change. At the start of the treatment the mean duration of bleeding was 5.1 +/- 0.3 days and at the end of the 6th month it was 3.8 +/- 0.2 days (p < 0.001) Klimonorm favorably affected the lipid profile. TC decreased significantly during the therapy: by 5.2% (p < 0.05) in all women and 7.1% (p < 0.05) in the high risk group. LDL cholesterol decreased slightly: by 4.3% (p < 0.05) in all women and was more pronounced in the high risk group (7.0%, p < 0.01). HDL cholesterol increased by 12.1% (p < 0.01) in all women and by 14.7% (p < 0.001) in the high risk group. TG were elevated slightly by 9.5% (p < 0.05) in all women and 3.9% (p > 0.05) in the high risk group. LDL/HDL ratio decreased from 2.7 to 2.3 in all women and from 3.0 to 2.4 (p < 0.05) in the high risk group. No significant changes in systolic and diastolic blood pressure were recorded. Body weight did not change significantly during the treatment period.