The effects of nomegestrol acetate subdermal implant (uniplant) on carbohydrate metabolism, serum lipoproteins and on hepatic function in women

Abstract

This study was undertaken to assess possible variations in body weight, blood pressure, fasting glucose, HbA1C, insulin, total cholesterol, HDL-C, LDL-C, triglycerides, SGPT, SGOT, GGT and bilirubin in women bearing a single subdermal Silastic implant containing 55 mg (10%) of nomegestrol acetate during two years. A total of eighteen volunteers of reproductive age who desired to avoid conception were enrolled in this study. Subjects were healthy women with no contraindications to hormonal contraception. All women were investigated before starting treatment and were followed up for one year. At the end of one year the capsules were removed and a new capsule was inserted. Fasting blood samples were drawn at 8:00 to 8:30 am twice prior to implant insertion and then at the first, third, sixth and twelfth months and every six months thereafter. Body weight increased from 54.9 ± 1.5 kg at admission to 55.3 ± 2.0 kg at 12 months of use (p<0.05) and to 56.0±2.7 kg at 24 months of use. A slight increase in both systolic and diastolic blood pressure was recorded at month 12 (p<0.01). At month 24, blood pressure was not significantly different from admission values. All levels were within the normal range. Insulin, HbA1C, LDL-C and GGT remained unchanged during twenty-four months of Uniplant use. A significant decrease in total cholesterol (p<0.05) was observed in the third month while a significant decrease in HDL-C (p<0.01) was observed only in the sixth month of Uniplant use. A significant increase in triglycerides (p<0.05) was observed only in the twelfth month. All changes in lipoproteins were inconsistent and all levels were within the normal range. Significant increases in fasting blood glucose levels (p<0.05 and p<0.01) were observed in the third and sixth month, respectively, for a total period of twenty-four months of Uniplant use. Significant decreases in SGOT (p<0.05, p<0.01 and p<0.05) were observed in the sixth, eighteenth and twenty-fourth months, respectively. A significant decrease in SGPT (p<0.05) was observed in the eighteenth month of Uniplant use. A significant increase in bilirubin (p<0.05) was observed only in the third month of Uniplant use. All changes observed in this study remained within the normal range. These results demonstrated that, within the normal range, variation of fasting glucose is not correlated with changes in insulin levels. The minor changes in serum lipoproteins, SGOT, SGPT and bilirubin were transient. Since no marked and consistent changes were observed and since all levels were within the normal range, it is concluded that no clinical effects on lipoproteins, carbohydrate metabolism, insulin levels and on hepatic function were observed in women using Uniplant for two years.