medrogestone and Body-Weight

Two sequential hormone replacement regimens, containing either estradiol valerate plus medroxyprogesterone acetate (E2V/MPA) or conjugated estrogens plus medrogestone (CE/MED), were compared with respect to effects on climacteric symptoms, lipid metabolism, and hemostasis.. In an open, multicenter study, 51 perimenopausal women were randomized to E2V/MPA and 50 to CE/MED. Assessment of climacteric complaints was performed at baseline and at months 1, 3, and 6. The effects on lipid and hemostatic variables were measured at baseline and at month 6. Quantitative data were analyzed using analysis of variance, the paired t-test or the chi2 Mantel-Hanszel test, where appropriate. RESILTS: Efficacy regarding treatment of climacteric symptoms was with E2V/MPA as good as with CE/MED, with a statistically significant reduction of most symptoms in both groups. After 6 months, total cholesterol and triglycerides had remained unchanged in both groups. High-density lipoprotein cholesterol showed no significant change with E2V/MPA, whereas an increase was noted in the CE/MED group (p<0.05). Low-density lipoprotein cholesterol was decreased with E2V/MPA (p<0.01) and was unchanged in the CE/MED group. Hemostatic parameters showed no significant changes after 6 months, with the exception of a decreased prothrombin time with E2V/MPA (p<0.05). Acceptability was excellent, expressed by the low incidence of treatment-related drop-outs in both groups.. E2V/MPA is a one tablet per day sequential HRT regimen, which is as effective and acceptable as hormone replacement therapy with CE/MED regarding treatment of climacteric symptoms. Neither preparation had negative effects on lipid metabolism and hemostatic variables.

Topics: Adult; Age Factors; Body Weight; Climacteric; Estradiol; Estrogen Replacement Therapy; Estrogens, Conjugated (USP); Female; Hemostasis; Humans; Lipid Metabolism; Medrogestone; Medroxyprogesterone Acetate; Menopause; Middle Aged; Postmenopause; Premenopause; Progesterone Congeners

Two sequential hormone replacement regimens, containing either estradiol valerate plus medroxyprogesterone acetate (E2V/MPA) or conjugated estrogens plus medrogestone (CE/MED), were compared with respect to effects on climacteric symptoms, lipid metabolism, and hemostasis.. In an open, multicenter study, 51 perimenopausal women were randomized to E2V/MPA and 50 to CE/MED. Assessment of climacteric complaints was performed at baseline and at months 1, 3, and 6. The effects on lipid and hemostatic variables were measured at baseline and at month 6. Quantitative data were analyzed using analysis of variance, the paired t-test or the chi2 Mantel-Hanszel test, where appropriate. RESILTS: Efficacy regarding treatment of climacteric symptoms was with E2V/MPA as good as with CE/MED, with a statistically significant reduction of most symptoms in both groups. After 6 months, total cholesterol and triglycerides had remained unchanged in both groups. High-density lipoprotein cholesterol showed no significant change with E2V/MPA, whereas an increase was noted in the CE/MED group (p<0.05). Low-density lipoprotein cholesterol was decreased with E2V/MPA (p<0.01) and was unchanged in the CE/MED group. Hemostatic parameters showed no significant changes after 6 months, with the exception of a decreased prothrombin time with E2V/MPA (p<0.05). Acceptability was excellent, expressed by the low incidence of treatment-related drop-outs in both groups.. E2V/MPA is a one tablet per day sequential HRT regimen, which is as effective and acceptable as hormone replacement therapy with CE/MED regarding treatment of climacteric symptoms. Neither preparation had negative effects on lipid metabolism and hemostatic variables.

Topics: Adult; Age Factors; Body Weight; Climacteric; Estradiol; Estrogen Replacement Therapy; Estrogens, Conjugated (USP); Female; Hemostasis; Humans; Lipid Metabolism; Medrogestone; Medroxyprogesterone Acetate; Menopause; Middle Aged; Postmenopause; Premenopause; Progesterone Congeners

An open prospective multicentric trial has been conducted over 6 months in 241 postmenopausal volunteers. One-hundred forty-one women had an intact uterus. All patients received a fixed peroral combination of conjugated estrogens CE (1.25 mg per day from day 1 to day 21) and medrogestone (5 mg per day from day 12 to day 21) followed by 7 days without substitution (day 22 to day 28). After 3 months of treatment, the managing physician could, according to the patient's clinical response, reduce the dosage of CE to 0.625 mg daily. This dose reduction took place in 79 patients (38.9%). The trial was designed to study efficacy, compliance and side-effects of this combination. Of the patients 68.9% showed a very good, 27.7% a good and 1.9% a satisfactory improvement of their preexisting subjective complaints. Of the patients 28.6% suffered from minor side-effects leading to drop-outs in 7.8% of the cases. Of the women participating in the study 92.2% completed the trial without from the treatment scheme. No serious complications have been noted. After 6 months of treatment, a regular bleeding pattern has been observed in 71.5% of the 144 non-hysterectomized women, an irregular pattern in 9.7% and amenorrhoea in 18.8%. Total cholesterol showed no change, whereas HDL rose significantly from 1.58 to 1.72 mmol/l (P < 0.01) resulting in a drop of Total-Cholesterol-HDL-Ratio of -8.8% (P < 0.01). LDL decreased from 3.71 +/- 1.56 to 3.45 +/- 1.39 (P < 0.05). Considering the two patient groups with and without estrogen reduction after 3 months, HDL increase was significant in both groups but was dose dependent. The HDL increase compared to the initial value was 5.7% with 0.625 mg CE and +10.8% with 1.25 mg CE, respectively. The fixed peroral combination of CE and medrogestone tested was effective, easy to administer and safe. The bleeding pattern observed was mostly regular. The pattern of serum lipids changed favorably in a significant way. Therefore, the use of this new peroral estrogen/progestin combination can be recommended for routine substitution in postmenopausal women.

Topics: Blood Pressure; Body Weight; Estrogen Replacement Therapy; Estrogens, Conjugated (USP); Female; Humans; Lipids; Medrogestone; Menopause; Middle Aged; Prospective Studies