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Sponsored by: |
Bionovo |
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Information provided by: | Bionovo |
ClinicalTrials.gov Identifier: | NCT00119665 |
The researchers propose a Phase II randomized, double-blind, placebo-controlled trial of 180 healthy postmenopausal women experiencing at least 5 hot flashes per day or 35 hot flashes per week. Women will be randomized to one of three arms: 4.5 grams/day (dry weight of extract) of MF101, 9.0 grams/day (dry weight of extract) of MF101 or placebo for 12 weeks.
Condition | Intervention | Phase |
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Hot Flashes |
Drug: MF101 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase II, Double-Blind, Placebo-Controlled, Randomized Clinical Trial Assessing Toxicity and Efficacy of MF101 for Hot Flashes and Menopausal Symptoms |
Ages Eligible for Study: | 40 Years to 60 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Alabama | |
University of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35233 | |
United States, California | |
University of California, San Francisco | |
San Francisco, California, United States, 94118 | |
United States, Minnesota | |
University of Minnesota | |
Minneapolis, Minnesota, United States, 55415 | |
United States, Tennessee | |
University of Tennessee Health Science Center | |
Memphis, Tennessee, United States, 38163 |
Principal Investigator: | Deborah Grady, MD, MPH | University of California, San Francisco |
Study ID Numbers: | MF-101-002 |
Study First Received: | July 6, 2005 |
Last Updated: | May 16, 2007 |
ClinicalTrials.gov Identifier: | NCT00119665 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Postmenopausal symptoms Hot Flashes Postmenopausal Hot Flashes |
Signs and Symptoms Hot Flashes Menopause |
Signs and Symptoms Hot Flashes |