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Sponsored by: |
Bionovo |
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Information provided by: | Bionovo |
ClinicalTrials.gov Identifier: | NCT00454441 |
Menopausal women often complain of difficulty sleeping and the transition from pre- to postmenopausal status is associated with an incresase in self-reported sleep disturbance. Hot flashes have been associated with self-reported measures of sleep disturbance and changes in sleep pattern as measured by plysomnography, including an increase in stage 4 and a latency or shortened time in rapid-eye movement sleep. Although there are some data on the effect of hormone replacement therapy on self-reported sleep measures in symptomatic postmenopausal women, there are no data on the effect of herbal extracts on subjective or objective measures of sleep quality in this population group. Actigraphy, the use of a device to record movement generally placed on the wrist, has been used over 20 years to provide objective data concerning sleep/wake patterns. The advantage of actigraphy over traditional polysomnography is that actigraphy can conveniently record continuously for 24-hours a day for longer periods of time.
Condition | Intervention | Phase |
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Sleep Quality Menopausal Symptoms |
Drug: MF101 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Sleep Quality in CHIMES (MF101) |
Estimated Enrollment: | 180 |
Study Start Date: | February 2006 |
Study Completion Date: | February 2007 |
Specific Aims:
Ages Eligible for Study: | 40 Years to 60 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
University of California, San Francisco | |
San Francisco, California, United States | |
United States, Minnesota | |
University of Minnesota Twin Cities Campus | |
Minneapolis, Minnesota, United States, 55415 |
Principal Investigator: | Kristine Ensrud, MD, MPH | University of Minnesota Twin Cities Campus |
Study ID Numbers: | MF101 Ancillary Study |
Study First Received: | March 28, 2007 |
Last Updated: | March 29, 2007 |
ClinicalTrials.gov Identifier: | NCT00454441 History of Changes |
Health Authority: | United States: Institutional Review Board |
Sleep Quality Menopausal Symptoms Actigraph Bionovo MF101 |
Menopause |