Table 2.
Summary of secondary endpoints: Mean change from baseline in absolute values for selected haemostatic parameters.
| Haemostatic parameter |
Treatment 1: 84 d LNG/EE; 7 d EE (n = 61)
|
Treatment 2: 21 d LNG/EE; 7 d no treatment (n = 67)
|
Treatment 3: 21 d DSG/EE; 7 d no treatment (n = 59)
|
||||||
|---|---|---|---|---|---|---|---|---|---|
| Baseline (Mean) | Overall (Mean) | Change from baseline | Baseline (Mean) | Overall (Mean) | Change from baseline | Baseline (Mean) | Overall (Mean) | Change from baseline | |
| D-dimer (ng/mL) | 350.5 | 415.3 | 64.8 | 291.0 | 379.3 | 88.3 | 314.0 | 482.5 | 168.5 |
| Factor II (%) | 111.2 | 117.8 | 6.6 | 109.9 | 118.0 | 8.1 | 109.9 | 118.6 | 8.7 |
| Factor VII (%) | 102.9 | 117.9 | 15.0 | 109.6 | 130.9 | 21.3 | 109.9 | 152.7 | 42.8* |
| Factor VIII (%) | 101.8 | 98.3 | − 3.5 | 99.8 | 100.6 | 0.7 | 102.1 | 107.4 | 5.3† |
| Protein C activity (%) | 117.0 | 110.3 | − 6.7 | 121.6 | 114.4 | − 7.2 | 110.6 | 111.3 | 0.74 |
| Protein C antigen (%) | 93.8 | 105.1 | 11.3 | 93.6 | 103.9 | 10.3 | 89.5 | 100.6 | 11.1 |
| Free protein S (%) | 90.2 | 93.6 | 3.4 | 92.2 | 96.4 | 4.2 | 92.1 | 73.7 | − 18.4‡ |
| Total protein S (%) | 101.0 | 90.0 | − 11.0 | 103.7 | 90.9 | − 12.8 | 98.0 | 78.5 | − 19.5‡ |
| Antithrombin (%) | 97.8 | 100.5 | 2.7 | 98.3 | 98.2 | − 0.13 | 99.2 | 98.3 | − 0.87z† |
| APTT-based APC resistance | 2.7 | 2.6 | − 0.12 | 2.7 | 2.5 | − 0.14 | 2.7 | 2.4 | − 0.29* |
| ETP-based APC resistance | 1.3 | 1.7 | 0.44 | 1.4 | 1.7 | 0.35 | 1.4 | 1.9 | 0.53† |
d, day; LNG, levonorgestrel; EE, ethinylestradiol; DSG, desogestrel; APC, activated protein C; APTT, activated partial thromboplastin time; ETP, endogenous thrombin potential.
*
p < 0.01 vs. Treatment 1;
†
p < 0.05 vs. Treatment 1;
‡
p < 0.001 vs. Treatment 1.