A double-blind comparative study of the effects of a 23-day oral contraceptive regimen with 20 μg ethinyl estradiol and 75 μg gestodene and a 21-day regimen with 30 μg ethinyl estradiol and 75 μg gestodene on hemostatic variables, lipids, and carbohydrate metabolism

Abstract 

In this double-blind study we compared the influence of two oral contraceptives, a 23-day regimen with 20 μg ethinyl estradiol and 75 μg gestodene (23-day 20/75) and a 21-day regimen with 30 μg ethinyl estradiol and 75 μg gestodene (21-day 30/75), on hemostatic variables, lipids, and carbohydrate metabolism. The volunteers received the preparations daily for six 28-day cycles. Hemostatic variables and lipids were measured at baseline and after six treatment cycles. Carbohydrate metabolism was assessed by determination of the area under the curve (AUC) of carbohydrate parameters after oral glucose tolerance tests performed at baseline and after three treatment cycles.

Data from 33 volunteers in each group were obtained. No significant differences between the effects of both treatments on the hemostatic system were detected. Neither the overall change of all hemostatic variables from baseline to treatment Cycle 6 [defined as primary target variable in the study] nor the change of any of the individual hemostatic parameters differed significantly between the treatment groups. Likewise, no significant nor clinically relevant differences in the effects of both treatments on the volunteers’ lipid profiles were detected. The data on carbohydrate variables suggested a slightly more favorable influence of the 23-day 20/75 regimen. The increase of the glucose AUCs after three cycles tended to be stronger with the 21-day 30/75 regimen than with the 23-day 20/75 regimen. In addition, the AUCs for insulin and C-peptide were slightly reduced after three cycles with the 23-day 20/75 regimen but slightly increased with the 21-day 30/75 regimen.

Both study treatments were safe and well tolerated by the volunteers as shown by the nature and frequency of adverse events, the routine laboratory examinations, and the physical and gynecological examinations. Both preparations provided adequate contraceptive reliability. The only pregnancy during treatment was attributable to intake errors.

In conclusion, the prolongation of the treatment phase of an oral contraceptives with 20 μg ethinyl estradiol does not evoke more pronounced metabolic effects than a conventional 21-day regimen with 30 μg ethinyl estradiol.

Keywords:  Oral contraceptives, Ethinyl estradiol, Gestodene, Hemostasis, Lipids, Carbohydrate metabolism, 23-day regimen