TABLE 1.
Hot flash frequency, severity, and bother during day time and night time
| Daytime vasomotor symptoms | Night vasomotor symptoms | |||||||||||
| n | Placebo (PBO) | n | MLE4901 (MLE) | Percentage point difference (MLE-PBO) | P | n | Placebo (PBO) | n | MLE4901 (MLE) | Percentage point difference (MLE-PBO) | P | |
| Frequency | ||||||||||||
| Day 3 | 34 | −25% (−35 to −16%) | 34 | −75% (−85 to −66%) | −50 (−62 to −38) | <0.0001 | 34 | −16% (−29 to −4%) | 34 | −70% (−83 to −57%) | −54 (−70 to −37) | <0.0001 |
| Week 1 | 34 | −24% (−33 to −15%) | 35 | −72% (−80 to −63%) | −48 (−59 to −37) | <0.0001 | 34 | −18% (−29 to −4%) | 35 | −63% (−72 to −54%) | −45 (−57 to −33) | <0.0001 |
| Week 2 | 34 | −29% (−38 to −19%) | 34 | −81% (−91 to −71%) | −52 (−66 to −39) | <0.0001 | 34 | −22% (−33 to −11%) | 34 | −75% (−86 to 63%) | −52 (−69 to −36) | <0.0001 |
| Week 3 | 34 | −30% (−40 to −19%) | 34 | −82% (−93 to −71%) | −52 (−67 to −37) | <0.0001 | 34 | −28% (−38 to −17%) | 34 | −76% (−86 to −65%) | −48 (−63 to −33) | <0.0001 |
| Week 4 | 34 | −29% (−40 to −18%) | 34 | −82% (−93 to −72%) | −53 (−68 to −38) | <0.0001 | 34 | −22% (−35 to −10%) | 34 | −78% (−90 to −65%) | −55 (−72 to −39) | <0.0001 |
| Severity | ||||||||||||
| Day 3 | 33 | −4% (−13 to 5%) | 34 | −40% (−48 to −31%) | −36 (−47 to −24) | <0.0001 | 33 | −6% (−16 to 4%) | 35 | −37% (−47 to −27%) | −31 (−44 to −18) | <0.0001 |
| Week 1 | 34 | −4% (−10 to 3%) | 35 | −38% (−44 to −32%) | −34 (−42 to −26) | <0.0001 | 34 | −1% (−8 to 6%) | 35 | −35% (−42 to −28%) | −34 (−43 to −25) | <0.0001 |
| Week 2 | 34 | −8% (−15 to −0.4%) | 34 | −43% (−50 to −36%) | −36 (−46 to −26) | <0.0001 | 34 | −4% (−12 to 4%) | 34 | −43% (−51 to −36%) | −40 (−50 to −29) | <0.0001 |
| Week 3 | 34 | −7% (−14 to −0.4%) | 34 | −47% (−54 to −41%) | −40 (−49 to −31) | <0.0001 | 34 | −4% (−12 to 3%) | 34 | −46% (−53 to −38%) | −41 (−51 to −32) | <0.0001 |
| Week 4 | 34 | −8% (−15 to −1%) | 34 | −45% (−52 to −38%) | −37 (−46 to −29) | <0.0001 | 34 | −3% (−11 to 5%) | 34 | −47% (−55 to −39%) | −44 (−54 to −34) | <0.0001 |
| Bother | ||||||||||||
| Day 3 | 34 | −7% (−16 to 1%) | 33 | −42% (−51 to −33%) | −35 (−47 to −23) | <0.0001 | 33 | −6% (−16 to 4%) | 35 | −37% (−47 to −27%) | −31 (−45 to −17) | 0.0001 |
| Week 1 | 34 | −7% (−14 to −1%) | 35 | −40% (−47 to −34%) | −33 (−41 to − 24) | <0.0001 | 34 | −2% (−9 to 5%) | 35 | −36% (−43 to −29%) | −33 (−43 to −24) | <0.0001 |
| Week 2 | 34 | −9% (−17 to −2%) | 34 | −47% (−55 to −40%) | −38 (−48 to −28) | <0.0001 | 34 | −5% (−13 to 3%) | 34 | −44% (−52 to −36%) | −40 (−51 to −28) | <0.0001 |
| Week 3 | 34 | −10% (−17 to −4%) | 34 | −50% (−57 to −44%) | −40 (−49 to −31) | <0.0001 | 34 | −7% (−14 to 1%) | 34 | −46% (−54 to −39%) | −40 (−50 to −29) | <0.0001 |
| Week 4 | 34 | −9% (−15 to −3%) | 34 | −51% (−58 to −45%) | −42 (−51 to −33) | <0.0001 | 34 | −5% (−13 to 3%) | 34 | −48% (−56 to −40%) | −43 (−54 to −32) | <0.0001 |
Results are presented as percentage change with 95% CIs from baseline on day 3 of treatment and mean weekly total for each week (week 1, week 2, week 3, and week 4) for both placebo and MLE4901 and treatment periods. Daytime symptoms: all symptoms from the time of getting up to going to bed; nighttime symptoms: all symptoms from going to bed to getting up the following morning.