Clinical and Metabolic Study of a New Monophasic Formulation Containing Ethinylestradiol and Gestodene

Abstract

Clinical and metabolic parameters were studied in healthy Thai women who took a new monophasic oral contraceptive formulation containing 30 mcg ethinylestra diol and 75 mcg gestoden ( A -15-levonorgestrel) over 12 cycles. 

One hundred and seven patients were included in the clinical evaluation which covered a total of 913 woman-cycles. No accidental pregnancy occurred. Cycle control was excellent and body weight and blood pressure were not affected during one year of pill use. Continuation rate after 12 months was 70.9 per cent. 

Of the 107 patients evaluated, 15 were included in the metabolic investigation which consisted of serial determinations of plasma glucose and insulin during periodic oral glucose tolerance testing (OGTT), serum cholesterol and lipoproteins and coagula tion and fibrinolytic factors. Determinations were done at baseline, cycle 3, 6 and 12. There were small changes in plasma insulin and blood glucose levels during the OGTT. The minimal changes in lipid metabolism included a rise in triglyceride concentration and a decrease in LDL, HDL and total cholesterol. APTT, PT and Factor VII remained unchanged throughout the cycles but the AT III levels significantly decreased. (Thai J Obstet Gynaecol 1989 ; 1:81-9.)