A Study of MF101 in Postmenopausal Women
HERBA
A Phase 3, Double-blind, Placebo-Controlled, Randomized Clinical Trial, Assessing Safety and Efficacy of MF101 for Hot Flushes and Menopausal Symptoms in Postmenopausal Women
1 other identifier
interventional
1,200
1 country
50
Brief Summary
This phase 3a study is designed to assess the safety and efficacy of MF101 on the frequency of moderate to severe hot flushes in postmenopausal women.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 19, 2009
CompletedFirst Posted
Study publicly available on registry
May 21, 2009
CompletedStudy Start
First participant enrolled
October 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedFebruary 8, 2012
February 1, 2012
1.3 years
May 19, 2009
February 6, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Determine the safety and efficacy of two doses of MF101 (5 g/day and 10 g/day) compared to placebo.
Safety will be measured through clinically significant findings in physical examinations, laboratory parameters, endometrial changes, abnormal uterine bleeding and any other adverse events. Efficacy will be measured by the mean change in frequency of moderate to severe hot flushes from baseline to treatment week 12.
12 weeks
Study Arms (3)
Placebo
PLACEBO COMPARATORMF101 5 g/day
EXPERIMENTALMF101 10 g/day
EXPERIMENTALInterventions
PO (orally) 5 g/day (administered twice a day, BID) for up to 12 weeks
PO (orally) 10 g/day (administered twice a day, BID) for up to 12 weeks
Eligibility Criteria
You may qualify if:
- Confirmed postmenopausal women aged 40-65
- Provide written informed consent
You may not qualify if:
- History of malignancy, with the exception of certain types of skin cancer or cervical cancer
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bionovolead
Study Sites (50)
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
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mary Tagliaferri, M.D, L.Ac.
Bionovo Inc.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 19, 2009
First Posted
May 21, 2009
Study Start
October 1, 2011
Primary Completion
February 1, 2013
Last Updated
February 8, 2012
Record last verified: 2012-02