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The effect of treatment on clinical symptoms and on endometrium, total body bone mineral density and lipid metabolism as well as the tolerability of the treatments with special emphasis on skin irritation and compliance were evaluated.
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The various progestogens can have more or less proliferative and pro-apoptotic effects than estradiol alone. Among the treatment schemes analyzed, the estradiol + dydrogesterone combination resulted in a higher apoptosis rate in relation to the proliferation rate and tibolone was associated with the lowest proliferation.
At baseline, plasma homocysteine levels did not differ between the groups. After 15 months of hormone treatment mean plasma homocysteine concentration was lowered by 12.6% compared with baseline (P < .001; analysis of variance for repeated measures). Plasma homocysteine levels were not altered in the control group. The interaction between treatment and time for homocysteine levels was significantly different between the groups (P < .001; analysis of variance for repeated measures). The decrease in plasma homocysteine levels correlated inversely with the increase in serum E2 levels after 3 and 12 months of hormone treatment (r = -.54, P < .05 and r = -.56, P < .05, respectively).
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Our study demonstrated that fulvestrant, an ER antagonist used in the treatment of ER-positive breast cancer, combined with E2 and DHD or in combination with tibolone, is not compromised in its efficacy in inducing apoptosis in ER-positive breast cancer cell lines in vitro.
Fear of weight gain is one of the main factors contributing to the poor compliance seen with hormone replacement therapy (HRT). Although an increase in weight can be a result of rehydration, (which in turn may alleviate some of the effects of skin ageing), many women consider weight gain to be cosmetically unacceptable. Moreover, excess body weight or certain patterns of body fat distribution can lead to health problems such as cardiovascular disease and breast cancer. The menopause is associated with a decrease in the resting metabolic rate that reduces the utilisation of calories and hence increases body weight. A number of studies have shown that weight gain is greatest in the peri-menopausal years. There also appears to be a redistribution of fat mass at the time of the menopause, with an increase in the waist-to-hip ratio. Although it is a common belief that HRT inevitably causes weight gain, available evidence suggests that this is not true. Indeed, some HRT regimens, such as continuous 17beta-oestradiol 2 mg/day combined with sequential dydrogesterone 10 mg/day for 14 days/cycle (Femoston), may actually help to prevent an increase in body fat mass and fat redistribution. Informing women about the effects of the menopause on body weight/fat distribution and the potential beneficial effects of some HRT regimens should help to improve HRT compliance.
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A randomized, double-blind, 1-year study was conducted. In a menopause clinic of a university hospital, 241 postmenopausal women using HRT were included for the study of histopathology and cell cycle analysis. Conjugated equine estrogens, 0.625mg/day, were administered for 25 days (days 1-25) of each month, and the following were also administered for 14 days (days 12-25): in group A ( n= 102), medroxyprogesterone acetate (MPA), 5 mg/day; in group B ( n= 66), MPA, 10mg/day; and in group C ( n= 73), dydrogesterone, 20mg/day. Endometrial sampling was performed after at least 10 months of treatment. Fifty-two premenopausal women were also enrolled for the comparative studies (group Y). The S-G2-M fractions in the cell cycle were used as the marker of proliferation.
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Threatened miscarriage is a common problem during pregnancy.
After treatment for six cycles serum concentrations of FSH and LH decreased significantly with 43.0% and 24.4%, respectively. Serum concentrations of 17 beta-oestradiol and oestrone increased significantly with 302% and 792%, respectively, and SHBG increased as well with 111% (P < 0.01). Serum total cholesterol decreased with 9.0% (P < 0.01). Serum VLDL-cholesterol did not change significantly. Serum LDL-cholesterol decreased with 16.3% (P < 0.01) and HDL-cholesterol increased with 8.0% (P < 0.01). This was accompanied with similar significant changes in the apolipoproteins: apolipoprotein A-I rose with 14.4% and apolipoprotein B decreased with 6.0%. Serum triglycerides and VLDL-triglycerides increased significantly with 14.4% and 17.9%, respectively. Lipoprotein (a) decreased with 17.5% (P < 0.01). These results more or less sustained at cycle 12 of treatment. Serum concentrations of antithrombin III and glucose did not change. Fibrinogen decreased slightly but significantly below the initial value.
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A prospective, open-label, randomized controlled clinical trial was conducted between February 2014 and December 2015. Totally 123 Chinese postmenopausal women with climacteric symptoms were included in this study and were randomly assigned to three groups: Group A received CEE 0.3 mg/micronized progesterone (MP) 100 mg daily; Group B received CEE 0.625 mg/MP 100 mg daily; and Group C received CEE 0.625 mg/dydrogesterone 10 mg daily. Drugs were given in a continuous sequential pattern. The duration of treatment was 12 months. Clinical, anthropometrical, and metabolic variables were measured. Data were analyzed according to intention-to-treat analysis, using Student's t-test and analysis of variance.
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Menorest is being tested in the prevention of postmenopausal bone loss. A phase II/III clinical program, that includes two double blind, dose-ranging, placebo-controlled, parallel group, 2-year studies, has started in 58 centers in Europe and South Africa. Four-hundred eighty women will be enrolled in the two studies (201 and 305). The objective of the studies is to evaluate the efficacy of Menorest at different doses and regimens, in the prevention of bone loss in early postmenopausal women. In study 201, the treatment regimen is 'cyclic sequential' (24 days of transdermal oestradiol during a 28-day cycle with progestin taken during the last 14 days of oestrogen administration). In study 305 the treatment regimen is "continuous sequential' (28 days of transdermal oestradiol during, a 28-day cycle with progestin taken during the last 14 days of oestrogen administration). The doses studied are 50, 75, 100 micrograms/day in study 201, and 25, 50, 75 micrograms/day in study 305, (the two studies are otherwise identical). All 'active-dose' treated groups receive dydrogesterone 20 mg/day during the last 14 days of Menorest administration and placebo tablets are given to the placebo patch group. The main entry criteria are natural or surgical menopause, (with hormonal confirmation) from 1 to 6 years, with no contra-indication to HRT and with a bone mineral density (BMD) at the lumbar spine with a T-score between 0 and -3. Women with severe vasomotor symptoms are excluded from the studies. The primary efficacy variable is the mean change from baseline, measured with dual energy X-ray absorptiometry (DXA) at 2 years, in the lumbar spine BMD (L1-L4). Whole body and hip BMD are also evaluated. Markers of bone turnover (bone-specific alkaline phosphatase, osteocalcin and CrossLaps) are monitored throughout the study. Blood samples are drawn on the third day of patch application at certain visits in order to monitor oestradiol levels and establish any potential correlation with activity on bone (BMD, bone markers). Besides routine safety analysis, lipid profile and coagulation factors are also monitored. Special attention is drawn to endometrial safety with endometrial aspiration or trans vaginal sonography (TVS) performed before study start, after 1 year and at 2 years of treatment.