Table 2.
Efficacy results in study 1, study 2 and pooled analysis
| Statistics | Study 1 | Study 2 | Pooled analysis | ||
|---|---|---|---|---|---|
| DRSP 4 mg (n = 713) | DRSP 4 mg (n = 858) | Desogestrel 0.075 mg (n = 332) |
DRSP 4 mg Total (n = 1.571) |
||
| Overall Pearl index | |||||
| Total number of exposure cycles | n | 7.638 | 6.691 | 2.487 | 14.329 |
| Pregnancy | n (%) | 3 (0.4%) | 5 (0.6%) | 1 (0.3%) | 8 (0.5%) |
| Overall Pearl index | % | 0.5106 | 0.9715 | 0.5227 | 0.7258 |
| 95%CI | Lower limit/upper limit | 0.1053/1.4922 | 0.3154/2.2671 | 0.0132/2.9124 | 0.3133/14301 |
| Overall Pearl index after correction for additional contraception and sexual activity status | |||||
| Total number of cycles with sexual activity and without additional contraception | n | 7.191 | 5.977 | 2.224 | 13.168 |
| Pregnancy | n (%) | 3 (0.4%) | 5 (0.6%) | 1 (0.3%) | 8 (0.5%) |
| Overall Pearl index after correction for additional contraception and sexual activity status | % | 0.5423 | 1.0875 | 0.5845 | 0.7898 |
| 95%CI | Lower limit/upper limit | 0.1118/1.5850 | 0.3531/2.5379 | 0.0148/3.2568 | 0.3410/1.5562 |
| Method failure Pearl index | |||||
| Total number of perfect medication cycles | n | 6.101 | 4.641 | 1.816 | 10.742 |
| Pregnancy | n (%) | 3 (0.4%) | 5 (0.6%) | 1 (0.3%) | 8 (0.5%) |
| Method failure Pearl index | % | 0.6392 | 1.4006 | 0.7159 | 0.9682 |
| 95%CI | Lower limit/upper limit | 0.1318/1.8681 | 0.4548/3.2684 | 0.0181/3.9885 | 0.4180/1.9077 |
| Overall pregnancy ratio | |||||
| % | 0.50% | 0.70% | 0.34% | 0.72% | |
| 95%CI | Lower limit/upper limit | 0.00/1.07% | 0.09/1.31% | 0.00/1.01% | 0.17/1.27% |
Abbreviation: DRSP, drospirenone.