TABLE 3.
Questionnaire items from HFRDIS which are likely related to improved sleep
| HFRDIS item | n | Placebo (PBO) | n | MLE4901 (MLE) | Percentage point difference (MLE-PBO) | P |
| Sleep | ||||||
| Day 3 | 28 | −16% (−45 to 13%) | 28 | −72% (−101 to −43%) | −56 (−97 to −15) | 0.0010a |
| Week 1 | 28 | −16% (−41 to 8%) | 28 | −61% (−86 to −36%) | −46 (−80 to −10) | 0.0148a |
| Week 2 | 28 | −11% (−34 to 13%) | 27 | −70% (−94% to −47%) | −60 (−93 to −27) | 0.0011a |
| Week 3 | 28 | −14% (−38 to 11%) | 27 | −67% (−93 to −42%) | −54 (−85 to −22) | 0.0017a |
| Week 4 | 28 | −20% (−42 to 1%) | 27 | −82% (−104 to −60%) | −62 (−93 to −32) | 0.0003a |
| Concentration | ||||||
| Day 3 | 29 | −25% (−46 to −4%) | 29 | −67% (−88 to −46%) | −42 (−72 to −12) | 0.0075a |
| Week 1 | 29 | −20% (−39 to −1%) | 29 | −55% (−74 to −36%) | −35 (−62 to −9) | 0.0118a |
| Week 2 | 29 | −13% (−37 to 11%) | 29 | −59% (−83 to −35%) | −46 (−81 to −12) | 0.0099a |
| Week 3 | 29 | −4% (−35 to 28%) | 29 | −56% (−87 to −24%) | −52 (−80 to −25) | 0.0007a |
| Week 4 | 29 | −14% (−32 to 4%) | 29 | −77% (−95 to −58%) | −62 (−88 to −37) | <0.0001a |
Results are presented as percentage change with 95% CIs from baseline on day 3 of treatment and mean weekly total for week 1, week 2, week 3, and week 4 of the treatment periods for both placebo and MLE4901.
aSkewed data. Italics—significant P value.
HFRDIS, Hot Flash Related Daily Interference Scale.