Sleep disturbances associated with menopause
Conditions
Brief summary
Change from baseline in WASO at Week 4 as measured by PSG
Detailed description
Change from baseline in WASO at Week 12 as measured by PSG, Change from baseline in SE at Week 4 as measured by PSG, Change from baseline in SE at Week 12 as measured by PSG, Change from baseline in PROMIS SD SF 8b total score at Week 4, Change from baseline in PROMIS SD SF 8b total score at Week 12, Change from baseline in ISI total score at Week 4, Change from baseline in ISI total score at Week 12, TEAEs, Abnormal laboratory parameters
Interventions
DRUGplacebo of BAY 3427080
DRUGBAY 3427080
Sponsors
Bayer Consumer Care AG, Bayer AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in WASO at Week 4 as measured by PSG | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in WASO at Week 12 as measured by PSG, Change from baseline in SE at Week 4 as measured by PSG, Change from baseline in SE at Week 12 as measured by PSG, Change from baseline in PROMIS SD SF 8b total score at Week 4, Change from baseline in PROMIS SD SF 8b total score at Week 12, Change from baseline in ISI total score at Week 4, Change from baseline in ISI total score at Week 12, TEAEs, Abnormal laboratory parameters | — |
Countries
Austria, Belgium, Czechia, Germany, Netherlands, Poland, Spain
Outcome results
None listed