Table 1.

Baseline characteristics for 177 women who were randomized and received study agent.

PlaceboSDG
CharacteristicsN = 62N = 115P
Continuous variablesMedian (range)Mann–Whitney
Mean ± SDtest
10-Year IBIS risk (%)4.3 (0.3–23.5)3.9 (0.5–23.1)0.76
4.9 ± 3.95.3 ± 5.0
Age at baseline RPFNA (years)40 (24–49)39 (22–49)0.23
39.7 ± 6.138.4 ± 6.7
BMI (kg/m2)24.9 (13.3–38.8)24.2 (17.0–38.5)0.33
25.8 ± 5.425.2 ± 5.4
Age at menarche (years)13 (10–17)13 (9–18)0.51
12.8 ± 1.412.9 ± 1.5
Age at first live birth (years)28 (17–37)28 (16–40)0.95
27.2 ± 5.727.6 ± 4.8
Categorical variablesNumberFisher exact
Current use of oral contraceptives(percent of randomization arm)test
 No55 (89%)108 (92%)0.58
 Yes7 (11%)9 (8%)
Parity
 Nulliparous15 (25%)39 (35%)0.17
 Parous45 (74%)73 (65%)
Prior biopsy
 No34 56%)70 (63%)0.42
 Yes27 (44%)42 (38%)
Prior history of atypical hyperplasia
 No57 (92%)106 (92%)1.00
 Yes5 (8%)9 (8%)
Number relatives with breast cancer
 018 (29%)26 (23%)0.73
 140 (66%)79 (71%)
 23 (5%)5 (5%)
 30 (0%)1 (1%)