THE EFFECTS OF NOMEGESTROL ACETATE SUBDERMAL IMPLANT (UNIPLANT) ON CARBOHYDRATE-METABOLISM, SERUM-LIPOPROTEINS AND ON HEPATIC-FUNCTION IN WOMEN

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 be aring a single subdermal Silastic implant containing 55 mg (10%) of no megestrol 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 hormo nal contraception. All women were investigated before starting treatme nt and were followed up for one year. At the end of one year the capsu les 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 th en 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 p ressure was not significantly different from admission values. Ah leve ls were within the normal range. Insulin, HbA1C, LDL-C and GGT remaine d unchanged during twenty-four months of Uniplant use. A significant d ecrease 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 th e sixth month of Uniplant use. A significant increase in triglycerides (p<0.05) was observed only in the twelfth month. All changes in lipop roteins 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 t otal period of twenty-four months of Uniplant use. Significant decreas es in SGOT (p<0.05, p<0.01 and p<0.05) were observed in the sixth, eig hteenth 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 th e third month of Uniplant use. All changes observed in this study rema ined 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, SG OT, SGPT and bilirubin were transient. Since no marked and consistent changes were observed and since all levels were within the normal rang e, it is concluded that no clinical effects on lipoproteins, carbohydr ate metabolism, insulin levels and on hepatic function were observed i n women using Uniplant for two years.