Table 1: Main results from the SMART trials.
| Study | Objective | Main results |
| SMART 1 | Effects on menopausal symptoms, metabolic parameters, and safety vs. BZA, CE/MPA, and PBO | - Reduction of the moderate-severe daily hot flushes (p < 0.05 vs. PBO) and its severity (p < 0.001 vs. PBO) - Improvements in sleep parameters (p < 0.05 vs. PBO) - Improvements in lipid parameters and only minor effects on some coagulation parameters - Endometrial, breast safety |
| SMART 2 | Safety and efficacy treating moderate to severe vasomotor symptoms vs. BZA, CE/MPA, and PBO | - Reduction in the number and severity of hot flashes (p < 0.001 vs. PBO) - Improvements in sleep parameters (p < 0.05 vs. PBO) - Improvements in satisfaction and quality of life (p < 0.05 vs. PBO) |
| SMART 3 | Efficacy and safety of two doses of TSEC vs. PBO for the treatment of moderate to severe VVA | - Increase in superficial and intermediate cells, and decrease in parabasal cells (p < 0.01 vs. PBO) - Improvements in satisfaction, vasomotor symptoms, sexual function, and quality of life (p < 0.05 vs. PBO) |
| SMART 4 | Endometrial safety and BMD effects vs. CE/MPA and PBO | - Endometrial safety similar to PBO. Bleeding and breast tenderness lower than HT (p < 0.05) - Improve lumbar spine and total hip BMD (p < 0.001 vs. PBO) Favorable safety/tolerability profile over 1 year |
| SMART 5 | Endometrial safety and BMD effects vs. BZA alone, HT, and PBO | - Low endometrial hyperplasia incidence (< 1%) in all groups - Cumulative amenorrhea rates similar to PBO and BZA and higher than HT (p < 0.001) - Improve lumbar spine and total hip BMD (p < 0.001 vs. PBO) - Breast tenderness similar to PBO and BZA and significantly lower than HT (p < 0.01) - Adverse event rates were similar among the groups - Serious AEs overall and AE-related discontinuation rates lower than HT |