Multinational, multicentre, randomised, open-label study evaluating the impact of a 91-day extended regimen combined oral contraceptive, compared with two 28-day traditional combined oral contraceptives, on haemostatic parameters in healthy women

Objectives To evaluate the impact of a 91-day extended regimen combined oral contraceptive (150 g levonorgestrel [LNG]/30 mu g ethinylestradiol [EE] for 84 days, followed by 10 mu g EE for seven days [Treatment 1]) compared with two traditional 21/7 regimens (21 days 150 mu g LNG/30 mu g EE [Treatment 2] or 150 mu g desogestrel [DSG]/30 mu g EE [Treatment 3], both with seven days' hormone free), on several coagulation factors and thrombin formation markers. Methods Randomised, open-label, parallel-group comparative study involving healthy women (18-40 years). The primary endpoint was change from baseline in prothrombin fragment 1 + 2 (F1 + 2) levels over six months. Results A total of 187 subjects were included in the primary analysis. In all groups, mean F1 + 2 values were elevated after six months of treatment. Changes were comparable between Treatments 1 and 2 (least squares mean change: 170 pmol/L and 158 pmol/L, respectively) but noticeably larger after Treatment 3 (least squares mean change: 592 pmol/L). The haemostatic effects of Treatment 1 were comparable to those of Treatment 2 and noninferior to those of Treatment 3 (lower limit of 95% confidence interval [- 18.3 pmol/L] > - 130 pmol/L). Conclusions The LNG/EE regimens had similar effects on F1 + 2. Noninferiority was demonstrated between extended regimen LNG/EE and DSG/EE.