|
Breast pain/tenderness
|
No significant differences in incidence of breast pain for any dose of CE/BZA, RLX 60 mg, or PBO [10]
|
No significant difference in number of women reporting ≥1 day of breast pain between CE/BZA and PBO [13]
|
Incidence of breast pain with CE 0.45 mg/BZA 20 mg and 0.625 mg/BZA 20 mg not significantly different from PBO [15]
|
No significant difference in number of women reporting ≥1 day of breast pain between CE/BZA and PBO
|
Rates of breast tenderness with CE 0.45 mg/BZA 20 mg and 0.625 mg/BZA 20 mg from 5.8%-9.4%, similar to PBO (5.4%-8.6%) [18]
|
|
Rates of breast tenderness with CE 0.45 mg/BZA 20 mg and 0.625 mg/BZA 20 mg were significantly lower than with CE 0.45 mg/MPA 1.5 mg (7.3%-24.3%; P <0.001) [18]
|
|
Compared with CE 0.45 mg/MPA 1.5 mg, breast pain incidence was significantly lower with CE 0.45 mg/BZA 20 mg at weeks 5–8 and 9–12 (P <0.05) and for CE 0.625 mg/BZA 20 mg at weeks 1–4, 4–8, and 9–12 (P <0.01) [17]
|
|
Abnormal mammogram findings
|
n (%) at 2 years: CE 0.45 mg/BZA 20 mg, 13 (4.4%)
|
ND
|
ND
|
ND
|
n (%) at 1 year: CE 0.45 mg/BZA 20 mg, 4 (0.9%)
|
|
CE 0.625 mg/BZA 20 mg, 11 (4.2%)
|
CE 0.625 mg/BZA 20 mg, 2 (0.4%)
|
|
RLX 60 mg, 9 (3.4%)
|
BZA 20 mg, 1 (0.4%)
|
|
PBO, 7 (2.6%) [100]
|
CE 0.45 mg/MPA 1.5 mg, 3 (1.4%)
|
|
PBO, 1 (0.2%) [18]
|
|
Breast density changes
|
No significant differences between groups in breast density
|
ND
|
ND
|
ND
|
No significant differences from PBO with CE 0.45 mg/BZA 20 mg or 0.625 mg/BZA 20 mg; CE 0.45 mg/MPA 1.5 mg significantly increased breast density vs. PBO (P <0.001)
|
|
Mean (SD) percentage change from baseline in percentage breast density at 2 years: CE 0.45 mg/BZA 20 mg, -0.39% (1.75%)
|
|
Adjusted percentage change from baseline in percentage breast density at 1 year, mean (SD): CE 0.45 mg/BZA 20 mg, -0.38% (0.22%)
|
|
CE 0.625 mg/BZA 20 mg, -0.05% (1.68%)
|
|
RLX 60 mg, -0.23% (1.76%)
|
|
PBO, -0.42% (1.72%) [100]
|
CE 0.625 mg/BZA 20 mg, -0.44% (0.22%)
|
|
BZA 20 mg, -0.24% (0.30%)
|
|
CE 0.45 mg/MPA 1.5 mg, 1.60% (0.35%)
|
|
PBO, -0.32% (0.23%) [18]
|
