Trial to Investigate the Effect of ESN364 in Early Postmenopausal Women Suffering From Hot Flashes
Status:
Completed
Trial end date:
2016-10-06
Target enrollment:
Participant gender:
Summary
The primary purpose of this study is to evaluate the effect of ESN364 on the severity and
frequency of hot flashes in early postmenopausal women suffering from hot flashes, in terms
of changes in weekly Hot Flash Score from baseline to Week 12.
This study will also evaluate the effect of ESN364 on the severity and frequency of hot
flashes at additional timepoints; hot flash interference on daily life, in terms of changes
from baseline over time in Hot Flash Related Daily Interference Scale (HFRDIS); the effect of
ESN364 on climacteric symptoms, in terms of changes from baseline over time in Leeds Sleep
Evaluation Questionnaire (LSEQ), Greene Climacteric Scale (GCS), and Sheehan Disability Scale
(SDS); pharmacodynamic (PD) effect; and safety and tolerability.