Back to resultsA Study of MF101 in Postmenopausal Women (HERBA)
Primary Purpose
Hot Flushes, Vasomotor Symptoms
Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
MF101 5 g/day
Placebo
MF101 10 g/day
Sponsored by
About this trial
This is an interventional treatment trial for Hot Flushes
Eligibility Criteria
Inclusion Criteria (limited):
- Confirmed postmenopausal women aged 40-65
- Provide written informed consent
Exclusion Criteria (limited):
- 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
Sites / Locations
- Arizona Research CenterRecruiting
- Visions Clinical Research CenterRecruiting
- Alta Bates Summit Medical CenterRecruiting
- Northern California ResearchRecruiting
- Genesis Center for Clinical Research
- Medical Center for Clinical ResearchRecruiting
- Downtown Women's Health CareRecruiting
- Visions Clinical ResearchRecruiting
- Meridien ResearchRecruiting
- Meridien ResearchRecruiting
- Suncoast Clinical ResearchRecruiting
- Compass ResearchRecruiting
- Suncoast Clinical ResearchRecruiting
- Meridien ResearchRecruiting
- Meridien ResearchRecruiting
- OB/GYN Specialists of the Palm BeachesRecruiting
- Soapstone Center for Clinical ResearchRecruiting
- Mount Vernon Clinical ResearchRecruiting
- Advanced Clinical ResearchRecruiting
- Johns Hopkins University
- Tufts University
- Robert Wood Johnson University Hospital
- Albuquerque Clinical TrialsRecruiting
- New Mexico Clinical Research & Osteoporosis CenterRecruiting
- Rochester Clinical ResearchRecruiting
- Eastern Carolina Women's CenterRecruiting
- PMG ResearchRecruiting
- Hawthorne Medical ResearchRecruiting
- Rapid Medical ResearchRecruiting
- Columbus Center for Women's Health ResearchRecruiting
- Clinical Trials of AmericaRecruiting
- Advanced Clinical Research - A Division of Medford Women's ClinicRecruiting
- The Clinical Trial CenterRecruiting
- University of PennsylvaniaRecruiting
- University of PittsburghRecruiting
- South Carolina Clinical ResearchRecruiting
- Coastal Carolina Research CenterRecruiting
- HCCA - Clinical Research SolutionsRecruiting
- HCCA - Clinical Research SolutionsRecruiting
- University of Tennessee at Memphis
- HCCA - Clinical Research SolutionsRecruiting
- Benchmark ResearchRecruiting
- Women Partners in Health/Professional Quality ResearchRecruiting
- Discovery Clinical TrialsRecruiting
- R/D Clinical ResearchRecruiting
- Advanced Clinical ResearchRecruiting
- University of VirginiaRecruiting
- National Clinical ResearchRecruiting
- National Clinical Research CenterRecruiting
- Seattle Women's Health, Research and GynecologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Placebo
MF101 5 g/day
MF101 10 g/day
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00906308
Brief Title
A Study of MF101 in Postmenopausal Women
Acronym
HERBA
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Unknown status
Study Start Date
October 2011 (undefined)
Primary Completion Date
February 2013 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bionovo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Menopausal women often experience debilitating menopausal vasomotor symptoms and associated insomnia. Until recently, vasomotor symptoms were often treated with estrogens, which are very effective; however, randomized clinical trials have shown that postmenopausal combination hormone therapy increases the risks for stroke, cardiovascular events, and breast cancer. New, more effective, and safer treatments for menopausal vasomotor symptoms are therefore needed.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hot Flushes, Vasomotor Symptoms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
MF101 5 g/day
Arm Type
Experimental
Arm Title
MF101 10 g/day
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
MF101 5 g/day
Intervention Description
PO (orally) 5 g/day (administered twice a day, BID) for up to 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
PO (orally) matched placebo (administered twice a day, BID) for up to 12 weeks
Intervention Type
Drug
Intervention Name(s)
MF101 10 g/day
Intervention Description
PO (orally) 10 g/day (administered twice a day, BID) for up to 12 weeks
Primary Outcome Measure Information:
Title
Determine the safety and efficacy of two doses of MF101 (5 g/day and 10 g/day) compared to placebo.
Description
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.
Time Frame
12 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria (limited):
Confirmed postmenopausal women aged 40-65
Provide written informed consent
Exclusion Criteria (limited):
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jesse Langon, MPH
Phone
510-4204182
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Tagliaferri, M.D, L.Ac.
Organizational Affiliation
Bionovo Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Research Center
City
Phoenix
State/Province
Arizona
Country
United States
Individual Site Status
Recruiting
Facility Name
Visions Clinical Research Center
City
Tucson
State/Province
Arizona
Country
United States
Individual Site Status
Recruiting
Facility Name
Alta Bates Summit Medical Center
City
Berkeley
State/Province
California
Country
United States
Individual Site Status
Recruiting
Facility Name
Northern California Research
City
Sacramento
State/Province
California
Country
United States
Individual Site Status
Recruiting
Facility Name
Genesis Center for Clinical Research
City
San Diego
State/Province
California
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Medical Center for Clinical Research
City
San Diego
State/Province
California
Country
United States
Individual Site Status
Recruiting
Facility Name
Downtown Women's Health Care
City
Denver
State/Province
Colorado
Country
United States
Individual Site Status
Recruiting
Facility Name
Visions Clinical Research
City
Boynton Beach
State/Province
Florida
Country
United States
Individual Site Status
Recruiting
Facility Name
Meridien Research
City
Bradenton
State/Province
Florida
Country
United States
Individual Site Status
Recruiting
Facility Name
Meridien Research
City
Brooksville
State/Province
Florida
Country
United States
Individual Site Status
Recruiting
Facility Name
Suncoast Clinical Research
City
New Port Richey
State/Province
Florida
Country
United States
Individual Site Status
Recruiting
Facility Name
Compass Research
City
Orlando
State/Province
Florida
Country
United States
Individual Site Status
Recruiting
Facility Name
Suncoast Clinical Research
City
Palm Harbor
State/Province
Florida
Country
United States
Individual Site Status
Recruiting
Facility Name
Meridien Research
City
St. Petersburg
State/Province
Florida
Country
United States
Individual Site Status
Recruiting
Facility Name
Meridien Research
City
Tampa
State/Province
Florida
Country
United States
Individual Site Status
Recruiting
Facility Name
OB/GYN Specialists of the Palm Beaches
City
West Palm Beach
State/Province
Florida
Country
United States
Individual Site Status
Recruiting
Facility Name
Soapstone Center for Clinical Research
City
Decatur
State/Province
Georgia
Country
United States
Individual Site Status
Recruiting
Facility Name
Mount Vernon Clinical Research
City
Sandy Springs
State/Province
Georgia
Country
United States
Individual Site Status
Recruiting
Facility Name
Advanced Clinical Research
City
Boise
State/Province
Idaho
Country
United States
Individual Site Status
Recruiting
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Tufts University
City
Springfield
State/Province
Massachusetts
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Robert Wood Johnson University Hospital
City
New Brunswick
State/Province
New Jersey
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Albuquerque Clinical Trials
City
Albuquerque
State/Province
New Mexico
Country
United States
Individual Site Status
Recruiting
Facility Name
New Mexico Clinical Research & Osteoporosis Center
City
Albuquerque
State/Province
New Mexico
Country
United States
Individual Site Status
Recruiting
Facility Name
Rochester Clinical Research
City
Rochester
State/Province
New York
Country
United States
Individual Site Status
Recruiting
Facility Name
Eastern Carolina Women's Center
City
New Bern
State/Province
North Carolina
Country
United States
Individual Site Status
Recruiting
Facility Name
PMG Research
City
Raleigh
State/Province
North Carolina
Country
United States
Individual Site Status
Recruiting
Facility Name
Hawthorne Medical Research
City
Winston-Salem
State/Province
North Carolina
Country
United States
Individual Site Status
Recruiting
Facility Name
Rapid Medical Research
City
Cleveland
State/Province
Ohio
Country
United States
Individual Site Status
Recruiting
Facility Name
Columbus Center for Women's Health Research
City
Columbus
State/Province
Ohio
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trials of America
City
Eugene
State/Province
Oregon
Country
United States
Individual Site Status
Recruiting
Facility Name
Advanced Clinical Research - A Division of Medford Women's Clinic
City
Medford
State/Province
Oregon
Country
United States
Individual Site Status
Recruiting
Facility Name
The Clinical Trial Center
City
Jenkintown
State/Province
Pennsylvania
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Individual Site Status
Recruiting
Facility Name
South Carolina Clinical Research
City
Columbia
State/Province
South Carolina
Country
United States
Individual Site Status
Recruiting
Facility Name
Coastal Carolina Research Center
City
Mt. Pleasant
State/Province
South Carolina
Country
United States
Individual Site Status
Recruiting
Facility Name
HCCA - Clinical Research Solutions
City
Franklin
State/Province
Tennessee
Country
United States
Individual Site Status
Recruiting
Facility Name
HCCA - Clinical Research Solutions
City
Jackson
State/Province
Tennessee
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Tennessee at Memphis
City
Memphis
State/Province
Tennessee
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
HCCA - Clinical Research Solutions
City
Smyrna
State/Province
Tennessee
Country
United States
Individual Site Status
Recruiting
Facility Name
Benchmark Research
City
Austin
State/Province
Texas
Country
United States
Individual Site Status
Recruiting
Facility Name
Women Partners in Health/Professional Quality Research
City
Austin
State/Province
Texas
Country
United States
Individual Site Status
Recruiting
Facility Name
Discovery Clinical Trials
City
Dallas
State/Province
Texas
Country
United States
Individual Site Status
Recruiting
Facility Name
R/D Clinical Research
City
Lake Jackson
State/Province
Texas
Country
United States
Individual Site Status
Recruiting
Facility Name
Advanced Clinical Research
City
West Jordan
State/Province
Utah
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
Country
United States
Individual Site Status
Recruiting
Facility Name
National Clinical Research
City
Norfolk
State/Province
Virginia
Country
United States
Individual Site Status
Recruiting
Facility Name
National Clinical Research Center
City
Richmond
State/Province
Virginia
Country
United States
Individual Site Status
Recruiting
Facility Name
Seattle Women's Health, Research and Gynecology
City
Seattle
State/Province
Washington
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Links:
URL
http://www.mf101.com
Description
Related Info
Learn more about this trial
A Study of MF101 in Postmenopausal Women
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