Table 1. Baseline characteristics of the PEPI Mammographic Density Study (PEPI-MDS) participants who were randomized to estrogen+progestin therapy, and the three analytic samples used in this study.
PEPI-MDS participants who were randomized to EPT | Analytic samples for serum progestogen analyses | Analytic samples for PGR genetic analyses | Analytic samples for serum progestogen & PGR interaction | |
---|---|---|---|---|
Total N | 358 | 280 | 260 | 210 |
Randomized to CEE+MPA cyclic | 114 | 74 | 88 | 57 |
Randomized to CEE+MPA continuous | 124 | 98 | 90 | 76 |
Randomized to CEE+MP | 120 | 108 | 82 | 77 |
Non-white ethnicity, No. (%) | 41 (11.5%) | 35 (12.5%) | 0 | 0 |
Age (mean±SD) | 56.1 ± 4.3 | 56.2 ± 4.1 | 56.5 ± 4.1 | 56.7 ± 3.9 |
BMI (mean±SD) | 26.2 ± 4.5 | 26.2 ± 4.6 | 26.1 ± 4.5 | 26 ± 4.6 |
Change in BMI | 0.09 ± 1.3 | 0.04 ± 1.2 | 0.1 ± 1.3 | 0.1 ± 1.3 |
Baseline progesterone level (pg/ml; mean±SD) | 202.2 ± 259.6 | 172.9 ± 44.4 | 208.6 ± 287.4 | 173.1 ± 45.2 |
Baseline mammographic density (%; mean±SD) | 24.1 ± 18.2 | 24.0 ± 18.2 | 24.5 ± 18.5 | 24.4 ± 18.5 |
Parous women, No. (%) | 321 (89.7%) | 253 (90.4%) | 236 (90.8%) | 191 (91.0%) |
Smoking status, No. (%) | ||||
Current | 39 (10.9%) | 29 (10.4%) | 31 (11.9%) | 23 (11.0%) |
Former | 130 (36.3%) | 101 (36.1%) | 101 (38.9%) | 80 (38.1%) |
Never | 189 (52.8%) | 150 (53.6%) | 128 (49.2%) | 107 (51.0%) |
Alcohol use, No. (%) | ||||
> 5.43 (g/day) | 110 (30.7%) | 82 (29.3%) | 83 (31.9%) | 64 (30.5%) |
> 0, = 5.43 (g/day) | 122 (34.1%) | 99 (35.4%) | 95 (36.5%) | 78 (37.1%) |
None | 126 (35.2%) | 99 (35.4%) | 82 (31.5%) | 68 (32.4%) |
Level of physical activity, No. (%) | ||||
High | 116 (32.4%) | 91 (32.5%) | 86 (33.1%) | 68 (32.4%) |
Medium | 123 (34.4%) | 103 (36.8%) | 92 (35.4%) | 81 (38.6%) |
Low | 119 (33.2%) | 86 (30.7%) | 82 (31.5%) | 61 (29.1%) |
Hysterectomy, No. (%) | 106 (29.6%) | 82 (29.3%) | 79 (30.4%) | 65 (31.0%) |
Prior use of hormone therapy, No. (%) | 203 (56.7%) | 157 (56.1%) | 158 (60.8%) | 127 (60.5%) |
Adherence to treatment assignment, No. (%) | 323 (90.2%) | 265 (94.6%) | 242 (93.1%) | 204 (97.1%) |
Abbreviations: CEE, conjugated equine estrogens; MPA, medroxyprogesterone acetate; MP, micronized progesterone