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Clinical Trial Summary

This is a randomized, placebo-controlled crossover study. Participants will be actively participating in the study for 6 months, and enrolled in the study for up to 1 year. During the first phase of the study, the participants will be randomized into either the placebo group or treatment group for 8 weeks following 1 week of baseline data collection (no treatment). Following this first phase, a no-treatment washout period of at least 3 weeks will be implemented for all participants. After the washout period, the randomized groups will switch from treatment to placebo group, or placebo to treatment group for an additional 8 week period. Hot flash frequency and severity will be documented using a daily hot flash diary and calculated using the Hot Flash Score questionnaire. The impact on quality of life will be documented by weekly Hot Flash Related Daily Interference Scale (HFRDIS) questionnaires.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT02952742
Study type Interventional
Source Midwestern Regional Medical Center
Contact
Status Withdrawn
Phase Phase 2
Start date November 2016
Completion date November 2018

See also
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