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(R)) 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 this 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 6 month it was 3.8 +/-0.2 days (p<0.001), Klimonorm(R) favorably affected 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 4.5% (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. (C) 2001 Prous Science. All rights reserved.