TABLE 3.
BI-RADS classification of mammograms at screening and at study end
| BI-RADS, n/N (%)a | 1 mg E2/100 mg P4 | 0.5 mg E2/100 mg P4 | 0.5 mg E2/50 mg P4 | 0.25 mg E2/50 mg P4 | Placebo |
| Screening | |||||
| 0 (Incomplete) | 0/415 (0.0) | 0/422 (0.0) | 1/421 (0.2) | 1/422 (0.2) | 0/151 (0.0) |
| [95% CI] | [0.0-0.9] | [0.0-0.9] | [0.0-1.3] | [0.0-1.3] | [0.0-2.4] |
| 1/2 (Normal) | 414/415 (99.8) | 422/422 (100.0) | 417/421 (99.1) | 418/422 (99.1) | 150/151 (99.3) |
| [95% CI] | [98.7-100.0] | [99.3-100.0] | [97.6-99.7] | [97.6-99.7] | [96.4-100.0] |
| 3/4 (Abnormal) | 1/415 (0.2) | 0/422 (0.0) | 3/421 (0.7) | 3/422 (0.7) | 1/151 (0.7) |
| [95% CI] | [0.0-1.3] | [0.0-0.9] | [0.2-2.1] | [0.2-2.1] | [0.0-3.6] |
| P valueb | 0.4627 | 0.2635 | >0.9999 | >0.9999 | |
| Study end | |||||
| 0 (Incomplete) | 2/300 (0.7) | 2/314 (0.6) | 1/325 (0.3) | 4/303 (1.3) | 0/98 (0.0) |
| [95% CI] | [0.1-2.4] | [0.1-2.3] | [0.0-1.7] | [0.4-3.4] | [0.0-3.7] |
| 1/2 (Normal) | 287/300 (95.7) | 301/314 (95.9) | 315/325 (96.9) | 294/303 (97.0) | 95/98 (96.9) |
| [95% CI] | [92.7-97.7] | [93.0-97.8] | [94.4-98.5] | [94.4-98.6] | [91.3-99.4] |
| 3/4 (Abnormal) | 11/300 (3.7) | 11/314 (3.5) | 9/325 (2.8) | 5/303 (1.7) | 3/98 (3.1) |
| [95% CI] | [1.8-6.5] | [1.8-6.2] | [1.3-5.2] | [0.5-3.8] | [0.6-8.7] |
| P valueb | >0.9999 | >0.9999 | >0.9999 | 0.4105 | |
BI-RADS, breast imaging and reporting and database system; CI, confidence interval; E2, 17β-estradiol; P4, progesterone.
a
Percentage was calculated using number of women with available mammograms as the denominator.
b
P value was calculated for active dose versus placebo.