Abstract
Thirty-four climacteric and 175 postmenopausal women were treated with three different preparations containing microcrystalline-17β-oestradiol and norethisterone acetate for climacteric symptoms and symptoms of oestrogen deficiency. 56 of the women (mean age 52 ± 5.2 years) were treated with trisekvensr` (Group I), 131 women (mean age 53 ± 6.3 years) with trisekvensr` forte (Group II) and 22 women (mean age 55.3 ± 5.2 years) with estrofemr` forte (Group III). The patients were followed for 2 1/2–3 1/2 years. All patients were subjected to a general and a gynaecological examination. Two or more serum samples were obtained from 145 of the patients during the treatment. Laboratory investigations included Autochemistr` analysis of serum levels of triglycerides, cholesterol, Ca++, Na+, K+, alkaline phosphatase, creatinine, glucose, protein, albumin, haptoglobin, zinc sulphate, Fe, TIBC, bilirubin, ALAT and ASAT and radioimmunoassay of serum levels of FSH, LH and low polar oestrogens (LPE).
S-cholesterol levels fell during the treatment in all three groups and in patients with elevated S-cholesterol levels the values were reverted to normal after 6 months' treatment. There was no change in S-triglycerides except in group I where a slight increase (P < 0.01) was observed after 24 months' treatment. There were no other changes in the values obtained from the Autochemistr` analysis. Serum levels of FSH and LH decreased during the treatment and this decrease was more pronounced in groups II and III. Serum LPE levels increased in group I for climacteric women to values observed during a normal luteal phase and in postmenopausal women to values found during the proliferative phase. In groups II and III the serum LPE values in postmenopausal women increased to levels corresponding to the luteal phase. Large individual variations in serum LPE levels were observed even during a rigorously standardized tablet intake, which might be explained by individual differences in absorption.
The therapy resulted in a disappearance of the climacteric symptoms (vasomotor symptoms, nervousness, irritability and sleep disturbances) and a considerable improvement of the symptoms caused by oestrogen deficiency (atrophic changes in the vulva, the vaginal mucosa, urethra and bladder, and the state of the skin and skeletal mineral depots). Few side effects were observed. 34 of the patients discontinued their treatment with the oestrogen preparations: 14 changed to another type of oestrogen and 20 stopped completely, 2 of them due to the discovery of mammary carcinoma. In general the oestrogen preparations tested were well tolerated. The oestrogen dose used in trisekvensr` forte and estrofemr` forte seems to be sufficient for an adequate oestrogen replacement therapy in climacteric and postmenopausal women.