Table 4.
Comparison of the effects of nomegestrol acetate/17β-oestradiol (N0MAC/E2) and levonorgestrel/ ethinylestradiol (LNG/EE) on carbohydrate indices (medians [interquartile ranges]).
| Carbohydrate indices | ||||||
|---|---|---|---|---|---|---|
| Treatment | Baseline | Cycle 3 | Cycle 6 | Change from baseline to cycle 6 | % change from baseline to cycle 6 | p-value* |
| AUC3 for glucose (hours X mmol/l) | ||||||
| N0MAC/E2 | 15.73 (3.49) | 15.95 (3.46) | 15.31 (3.75) | 0.79 (3.37) | 6.1 (25.7) | 0.002 |
| LNG/EE | 14.12 (3.26) | 16.19 (4.58) | 16.34 (4.71) | 2.08 (3.16) | 13.9 (24.5) | |
| Incremental AUC3 for glucose (hours X mmol/l) | ||||||
| N0MAC/E2 | 1.15 (3.35) | 1.27 (3.29) | 1.25 (2.93) | 0.61 (3.02) | 25.4 (2076) | < 0.001 |
| LNG/EE | 0.64 (3.06) | 2.95 (4.05) | 2.87 (4.03) | 2.07 (3.50) | 56.5 (273.0) | |
| AUC3 for insulin (hours X mmol/l) | ||||||
| N0MAC/E2 | 585.6 (304.0) | 654.5 (488.3) | 620.3 (3571) | −4.1 (240.6) | −0.9 (33.1) | < 0.001 |
| LNG/EE | 540.6 (218.7) | 702.6 (375.0) | 704.7 (356.0) | 1779 (275.2) | 26.4 (53.7) | |
| Incremental AUC3 for insulin (hours X mmol/l) | ||||||
| N0MAC/E2 | 4476 (302.3) | 496.1 (3873) | 481.1 (270.5) | −29.5 (241.3) | −6.1 (571) | 0.002 |
| LNG/EE | 432.1 (179.2) | 592.8 (348.5) | 588.3 (284.7) | 1479 (299.8) | 35.9 (69.5) | |
| HbA1c (%) | ||||||
| N0MAC/E2 | 5.35 (0.35) | 5.40 (0.30) | 5.30 (0.30) | 0.00 (0.20) | 0.0 (3.7) | 0.37 |
| LNG/EE | 5.30 (0.20) | 5.40 (0.20) | 5.30 (0.30) | 0.00 (0.20) | 0.0 (3.7) | |
AUC3, area under the curve over three hours; HbA1c, haemoglobin type A1c.
*
The Cochran-Mantel-Haenszel test adjusted for age class using standardised midranks, applied on the absolute changes from baseline to cycle 6. A p-value ≤ 0.05 indicates that the difference from baseline to cycle 6 (NOMAC/ E2 vs LNG/EE) was statistically significant.