Climacteric symptoms and control of the cycle in women aged 35 years or older taking an oral contraceptive with 0.150 mg desogestrel and 0.020 mg ethinylestradiol.

In a multicenter prospective trial, 58 healthy women aged between 35 and 49 years were studied for one year (639 cycles) while taking an oral contraceptive (OC) containing desogestrel 0.150 mg and ethinylestradiol (EE) 0.020 mg. Efficacy, control of the cycle, side effects, complaints, and climacteric symptoms were monitored after 3, 6, 9 and 12 cycles. No pregnancies occurred during the study period. Spotting gradually decreased from 29.3% in cycle 1 to 4.2% in cycle 12, while breakthrough bleeding (BTB) disappeared after cycle 7. One case of superficial thrombophlebitis and 3 cases of minor side effects were registered. With regard to the complaints, breast tenderness, headache, and depression gradually decreased during the study (basal vs. 12-month data: 50.9% vs. 31.2%, 48.3% vs. 18.7%, 39.6% vs. 20.8%, respectively), while nausea disappeared after three months. A significant treatment-dependent reduction of climacteric symptoms was obtained after cycle 3 and this tendency was maintained up to cycle 12. No changes were registered in body mass index (BMI) or blood pressure.

Effects of an oral contraceptive combination containing 0.150 mg desogestrel plus 0.020 mg ethinyl estradiol on healthy premenopausal women.

Twenty-six healthy premenopausal outpatients from the Menopause Clinic of the University of Bologna were treated with a combination pill containing 0.020 mg of ethinyl estradiol and 0.150 mg of desogestrel for one year. Throughout the treatment period, clinical and laboratory monitoring was periodically performed, and women were asked about the occurrence of climacteric symptoms. This formulation relieved climacteric symptoms, and did not adversely affect lipids and clotting factors, except for a slight increase in serum triglycerides. Laboratory data also suggest a beneficial effect on bone metabolism.

An open prospective study on the effects on carbohydrate metabolism of an oral monophasic contraceptive containing gestodene (WL-70).

The effects of a monophasic oral contraceptive (gestodene 75mcg + ethinylestradiol 30 mcg) on plasma glucose (PG) and insulin (IRI) responses to an oral glucose load (OGTT) and on glycosylated haemoglobin Alc (HbAlc), fructosamine (Fr), total cortisol (FT) and transcortin (CBG) were studied in 30 healthy women. Blood samples were taken before treatment and after 6 and 12 cycles. After 6 and 12 months, OGTT-PG and IRI levels showed substantially unchanged values; for HbAlc and Fr the same behaviour was seen with the exception of the latter between 6 and 12 months; FT and CBG showed significant rises. All recorded values were in the normal range. The basal and dynamic PG and IRI behaviour failed to show any significant variations between pre-treatment values and those after 6 and 12 months of OC administration. Other data showed a substantial neutrality for this oral contraceptive containing gestodene.

Capillary glucose determination in the screening of gestational diabetes.

Paired capillary-venous blood samples were obtained from 418 pregnant women undergoing an oral glucose challenge test (GCT) for the screening of gestational diabetes (GD). The relationship between capillary and plasma glucose concentrations was investigated in order to establish a capillary GCT threshold. Plasma glucose was assayed by the glucose oxidase method and capillary glucose using Reflocheck Glucose strips and a Reflocheck reflectance meter. During GCT the capillary values exceeded plasma glucose values by a mean difference of 10-12 mg/dl fasting and 22-24 mg/dl after 1 h. A high correlation between the glucose values of the two techniques was found, particularly for those at 1 h, with corresponding capillary determinations being 20 mg/dl above plasma values. The sensitivity, specificity and predictive value of the various capillary thresholds investigated in detecting GD corresponded substantially to the accuracy of plasma thresholds 20 mg/dl lower. The receiver operator characteristic curves of the plasma and capillary thresholds were similar in shape and the optimal cut-off point for performing a diagnostic test was set at 135 and 155 mg/dl, respectively. These cut-off values should be reconsidered in the light of the costs and perinatal outcome.

Continuous subcutaneous insulin infusion versus intensive conventional insulin therapy in type I and type II diabetic pregnancy.

Two groups of pregnant diabetic women, fifteen with type I and fourteen with type II diabetes, were randomly assigned either to CSII or to ICT and the subgroups compared with respect to glycaemic control, insulin requirement and perinatal out-come. Ten non-diabetic pregnant women served as controls for the variations in the metabolic parameters considered (24-hour mean blood glucose and glycosylated hemoglobin). Strict glycaemic control was achieved and maintained by both regimens before week 13 in all patients with type I and in 57.1% of patients with type II diabetes. The mean insulin requirements in the type I group increased up to week 34-36 and then stabilized to term in patients receiving CSII and rose progressively to term in those receiving ICT. In the type II group insulin requirements rose up to week 36 in patients receiving CSII and up to week 32 in those receiving ICT, stabilizing thereafter on both regimens. No significant differences in mean insulin requirement at the different stages of gestation were found between the patients receiving CSII and those receiving ICT of either group. Perinatal outcome was satisfactory in both groups, although control of foetal growth was better with ICT than with CSII. CSII is a practical, safe and effective method of maintaining maternal normoglycemia in pregnancy but for the present we cannot consider it superior to ICT in the treatment of pregnant diabetic women.