Clinical experience with a low-dose combination of estradiol valerate and levonorgestrel. Double-blind comparative study between SH D 386 F and Cyclabil. Effects on symptoms, lipids and endometrial condition

Abstract

In a double blind study of the effects of hormone replacement therapy in climacteric women, two different dosages of estradiol--17 beta valerate and levonorgestrel, with the same ratio between the amounts of the two steroids (Cyclabil and the trial preparation having the code number SH D 386 F respectively), were compared. The differences in effects on symptoms, certain humoral parameters including serum lipids, and endometrial histology before and after 12 months of therapy were evaluated. The study population consisted of 120 healthy women in the age range 41-63 years, many of whom had undergone previous estrogen treatment. All had typical climacteric symptoms and were peri- or postmenopausal. There were no significant differences between the two preparations as regards the effects on symptoms--except for episodes of hot flushes and depression (loss of confidence), which were more frequent during treatment with the higher dosage. One of the main objects of the study was to determine whether the lower dosage would be sufficient to prevent the development of endometrial hyperplasia. To this end, endometrial samples were collected before and after 12 months of treatment, using "Mi-markTM" disposable equipment for endometrial cytology/histology. No significant endometrial hyperplasia was found in either of the groups during the period of investigation. The serum lipid pattern was evidently more influenced in the group treated with Cyclabil. The drop-out rate was 20%, most of them being due to side effects of mild to moderate severity such as undesirable withdrawal bleedings or unsatisfactory relief of symptoms, which sometimes resulted in a wish to return to earlier treatment regimens.