Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
1200 participants
INTERVENTIONAL
2011-10-31
Brief Summary
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Detailed Description
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MF101, a botanical extract, is a non-hormonal investigational treatment being tested in a randomized, double-blind, placebo-controlled phase 3a clinical trial to assess the safety and efficacy of MF101 on the frequency of moderate to severe hot flushes in postmenopausal women. Approximately 1200 healthy post-menopausal women, aged 40-65, with moderate to severe hot flushes will be enrolled to determine the safety and efficacy of two doses of MF101 (5 g/day and 10 g/day) compared to placebo after 12 weeks of treatment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo
PO (orally) matched placebo (administered twice a day, BID) for up to 12 weeks
MF101 5 g/day
MF101 5 g/day
PO (orally) 5 g/day (administered twice a day, BID) for up to 12 weeks
MF101 10 g/day
MF101 10 g/day
PO (orally) 10 g/day (administered twice a day, BID) for up to 12 weeks
Interventions
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MF101 5 g/day
PO (orally) 5 g/day (administered twice a day, BID) for up to 12 weeks
Placebo
PO (orally) matched placebo (administered twice a day, BID) for up to 12 weeks
MF101 10 g/day
PO (orally) 10 g/day (administered twice a day, BID) for up to 12 weeks
Eligibility Criteria
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Inclusion Criteria
* Provide written informed consent
Exclusion Criteria
* Known carrier of BRCA1 or BRCA2
* Abnormal mammogram or breast examination suggestive of cancer within 9 months of screening
* Endometrial hyperplasia, polyps or abnormal uterine masses (with the exception of fibroids)
* Clinical evidence of active ischemic heart disease, history of cardiovascular disease, uncontrolled hypertension, or a history of transient ischemic attacks or cerebrovascular accidents
* History of deep vein thrombosis, pulmonary embolism, severe chronic diarrhea, chronic constipation, uncontrolled inflammatory bowel syndrome or disease (IBS or IBD), or unexplained weight loss
* Active liver disease or gall bladder disease
* History of chronic hepatitis B, hepatitis C, hepatitis within 3 months, or HIV infection
* Use of prescription medications or herbal/dietary supplements for the treatment of hot flushes or those with known estrogenic/progestogenic activity within required wash-out timeframes
* Use of selective receptor modulators (SERMs), aromatase inhibitors, gonadotropin-releasing hormone agonists, selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs), gabapentin or clonidine within required wash-out timeframes
* Chronic use of morphine or other opiates
40 Years
65 Years
FEMALE
Yes
Sponsors
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Bionovo
INDUSTRY
Responsible Party
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Principal Investigators
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Mary Tagliaferri, M.D, L.Ac.
Role: STUDY_DIRECTOR
Bionovo Inc.
Locations
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Arizona Research Center
Phoenix, Arizona, United States
Visions Clinical Research Center
Tucson, Arizona, United States
Alta Bates Summit Medical Center
Berkeley, California, United States
Northern California Research
Sacramento, California, United States
Genesis Center for Clinical Research
San Diego, California, United States
Medical Center for Clinical Research
San Diego, California, United States
Downtown Women's Health Care
Denver, Colorado, United States
Visions Clinical Research
Boynton Beach, Florida, United States
Meridien Research
Bradenton, Florida, United States
Meridien Research
Brooksville, Florida, United States
Suncoast Clinical Research
New Port Richey, Florida, United States
Compass Research
Orlando, Florida, United States
Suncoast Clinical Research
Palm Harbor, Florida, United States
Meridien Research
St. Petersburg, Florida, United States
Meridien Research
Tampa, Florida, United States
OB/GYN Specialists of the Palm Beaches
West Palm Beach, Florida, United States
Soapstone Center for Clinical Research
Decatur, Georgia, United States
Mount Vernon Clinical Research
Sandy Springs, Georgia, United States
Advanced Clinical Research
Boise, Idaho, United States
Johns Hopkins University
Baltimore, Maryland, United States
Tufts University
Springfield, Massachusetts, United States
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States
Albuquerque Clinical Trials
Albuquerque, New Mexico, United States
New Mexico Clinical Research & Osteoporosis Center
Albuquerque, New Mexico, United States
Rochester Clinical Research
Rochester, New York, United States
Eastern Carolina Women's Center
New Bern, North Carolina, United States
PMG Research
Raleigh, North Carolina, United States
Hawthorne Medical Research
Winston-Salem, North Carolina, United States
Rapid Medical Research
Cleveland, Ohio, United States
Columbus Center for Women's Health Research
Columbus, Ohio, United States
Clinical Trials of America
Eugene, Oregon, United States
Advanced Clinical Research - A Division of Medford Women's Clinic
Medford, Oregon, United States
The Clinical Trial Center
Jenkintown, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
South Carolina Clinical Research
Columbia, South Carolina, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, United States
HCCA - Clinical Research Solutions
Franklin, Tennessee, United States
HCCA - Clinical Research Solutions
Jackson, Tennessee, United States
University of Tennessee at Memphis
Memphis, Tennessee, United States
HCCA - Clinical Research Solutions
Smyrna, Tennessee, United States
Benchmark Research
Austin, Texas, United States
Women Partners in Health/Professional Quality Research
Austin, Texas, United States
Discovery Clinical Trials
Dallas, Texas, United States
R/D Clinical Research
Lake Jackson, Texas, United States
Advanced Clinical Research
West Jordan, Utah, United States
University of Virginia
Charlottesville, Virginia, United States
National Clinical Research
Norfolk, Virginia, United States
National Clinical Research Center
Richmond, Virginia, United States
Seattle Women's Health, Research and Gynecology
Seattle, Washington, United States
Countries
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Central Contacts
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Jesse Langon, MPH
Role: CONTACT
Related Links
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Related Info
Other Identifiers
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MF-101-004
Identifier Type: -
Identifier Source: org_study_id
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