Clinical and metabolic effects of gestodene and levonorgestrel.

The new low-dose combination oral contraceptive (OC) containing 75 mcg of the new progestogen gestodene (GTD) plus 30 mcg ethinyl estradiol (EE) was clinically tested and compared with a levonorgestrel (LNG) combined pill (150 mcg LNG + 30 mcg EE). In a randomized clinical comparative study (A) 176 women were treated with the GTD-Containing pill and 185 with the LNG-containing pill for 6 cycles. This study was followed by a 2nd multicenter study (B) which comprised 707 patients taking the GTD-Containing pill for up to 24 cycles (total=9947 cycles). In a 3rd study (C) the metabolic effects were assessed using a randomly organized baseline control trial (pretreatment/treatment cycles) 30 patients received the GTD-containing pill and 30 received the LNG- containing pill. Carbohydrate metabolism lipid metabolism and blood clotting were investigated and an interim analysis was performed after 6 OC cycles. No pregnancies and no severe side effects occurred in any if these studies. Intermenstrual bleeding decreased as usual during treatment. In the total number of gestodene cycles in studies A and B there was a 6.9% incidence of spotting and 0.8% incidence of breakthrough bleeding and a 0.7% incidence of both spotting and breakthrough bleeding in studies A and B patients taking gestodene. Amenorrhea occurred in 0.6% of cycles. Body weight remained unchanged (+or- 2 kg) after 24 cycles in 80.5% of study B patients taking gestodene. Blood pressure remained normal in about 95% of all study B patients; a normalization was observed in >60% of patients with previously elevated blood pressure. No clinically relevant changes in carbohydrate metabolism lipid metabolism or blood clotting were observed in study C. The new GTD-containing low-dose combination pill proved to be a safe and reliable contraceptive agent. (authors)