Table 1.
Mean on-trial endometrial thickness (mm) by treatment group in intention to treat population and per protocol population
| Population | Least square mean (95% CI) | Time p | Treatment p | |
|---|---|---|---|---|
| Oral E2 plus Vaginal P4 | Placebo | |||
|
Intention to treat population (430 women N=2105) |
3.03 (2.83, 3.22) | 1.60 (1.52, 1.72) | 0.54 | <0.001 |
|
Per protocol population (366 women N=1619) |
3.13 (2.89,3.35) | 1.57 (1.46, 3.35) | 0.67 | <0.001 |
Least square means were estimated from a mixed effect linear model, including post-randomization values.
Time*Treatment interaction in ITT population p=0.17, PP population p=0.29
N=number of endometrial thickness measures, CI=confidence interval, E2=estradiol, P4=progesterone