Table 4.
4-Week and 12-Week Parallel-group Treatment Comparisons: Vasomotor Composite1 and Neuropsychological Compositea
| Placebo | 50 mg | 100 mg | p-value | |
|---|---|---|---|---|
| 4-week Change, mean (SE)b | ||||
| Vasomotor Composite | (n=23) | (n=21) | (n=22) | |
| Change over 4 weeks | 1.76 (0.58) | 0.92 (0.57) | 1.30 (0.61) | 0.59 |
| Neuropsychological Composite | (n=24) | (n=22) | (n=23) | |
| Change over 4 weeks | 2.41 (0.82) | 0.98 (0.79) | 1.56 (0.84) | 0.73 |
| 12-week Change, mean (SE)c | ||||
| Vasomotor Composite | (n=23) | (n=21) | (n=22) | |
| Change over 12 weeks | 0.94 (0.41) | 0.56 (0.45) | 1.59 (0.43) | 0.25 |
| Change by week | 0.90 | |||
| Week 4 | 1.38 (0.54) | 1.00 (0.58) | 2.20 (0.57) | |
| Week 8 | 1.13 (0.54) | 0.50 (0.58) | 1.89 (0.57) | |
| Week 12 | 0.30 (0.54) | 0.20 (0.60) | 0.69 (0.57) | |
| Neuropsychological Composite | (n=24) | (n=22) | (n=23) | |
| Change over 12 weeks | 5.10 (0.67)3 | 4.04 (0.73) | 4.46 (0.68) | 0.57 |
| Change by week | 0.57 | |||
| Week 4 | 2.47 (0.80) | 0.89 (0.85) | 1.23 (0.81) | |
| Week 8 | 5.64 (0.82) | 3.98 (0.88) | 4.79 (0.82) | |
| Week 12 | 7.21 (0.80) | 7.27 (0.88) | 7.39 (0.82) | |
See table 2 for definitions of vasomotor composite and neuropsychological composites
Group comparisons by general linear model. Dependent variable = 4-week change from baseline composite score; primary independent variables are randomized treatment. Covariates include baseline composite score.
Group comparisons by mixed effects linear models. Dependent variable = change from baseline composite score (at weeks 4, 8, 12); primary independent variables are randomized treatment and follow-up week (4, 8, 12). Covariates include baseline composite score, inclusion in crossover study (0,1). 12-week analyses incorporate 12 crossover participants (6 placebo, 6 100 mg) for their entire 12-week period (i.e., crossover participants contribute outcome data at 0, 4, 8, and 12 weeks). Treatment assignment for crossovers is their 8-week crossover assignment.