Hot FlushesPhase 3HERBANCT00906308
A Study of MF101 in Postmenopausal Women
A Phase 3 study testing MF101 5 g/day and MF101 10 g/day in people with Hot Flushes and Vasomotor Symptoms, run by Bionovo at 50 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hot Flushes, Vasomotor Symptoms
- What is being tested?
- MF101 5 g/day and MF101 10 g/day
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,200 participants
- Where
- 50 sitesUnited States
- Study dates
- Oct 2011to Feb 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Confirmed postmenopausal women aged 40-65
- Provide written informed consent
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
50 sites in 1 country.
Jesse Langon, MPH contact
50 sites in 1 country
United States50 sites, 50 recruiting
- Recruiting
Albuquerque Clinical Trials
Albuquerque, New Mexico
- Recruiting
New Mexico Clinical Research & Osteoporosis Center
Albuquerque, New Mexico
- Recruiting
Benchmark Research
Austin, Texas
- Recruiting
Women Partners in Health/Professional Quality Research
Austin, Texas
- Not yet recruiting
Johns Hopkins University
Baltimore, Maryland
- Recruiting
Alta Bates Summit Medical Center
Berkeley, California
- Recruiting
Advanced Clinical Research
Boise, Idaho
- Recruiting
Visions Clinical Research
Boynton Beach, Florida
- Recruiting
Meridien Research
Bradenton, Florida
- Recruiting
Meridien Research
Brooksville, Florida
- Recruiting
University of Virginia
Charlottesville, Virginia
- Recruiting
Rapid Medical Research
Cleveland, Ohio
- Recruiting
South Carolina Clinical Research
Columbia, South Carolina
- Recruiting
Columbus Center for Women's Health Research
Columbus, Ohio
- Recruiting
Discovery Clinical Trials
Dallas, Texas
- Recruiting
Soapstone Center for Clinical Research
Decatur, Georgia
- Recruiting
Downtown Women's Health Care
Denver, Colorado
- Recruiting
Clinical Trials of America
Eugene, Oregon
- Recruiting
HCCA - Clinical Research Solutions
Franklin, Tennessee
- Recruiting
HCCA - Clinical Research Solutions
Jackson, Tennessee
- Recruiting
The Clinical Trial Center
Jenkintown, Pennsylvania
- Recruiting
R/D Clinical Research
Lake Jackson, Texas
- Recruiting
Advanced Clinical Research - A Division of Medford Women's Clinic
Medford, Oregon
- Not yet recruiting
University of Tennessee at Memphis
Memphis, Tennessee
- Recruiting
Coastal Carolina Research Center
Mt. Pleasant, South Carolina
- Recruiting
Eastern Carolina Women's Center
New Bern, North Carolina
- Not yet recruiting
Robert Wood Johnson University Hospital
New Brunswick, New Jersey
- Recruiting
Suncoast Clinical Research
New Port Richey, Florida
- Recruiting
National Clinical Research
Norfolk, Virginia
- Recruiting
Compass Research
Orlando, Florida
- Recruiting
Suncoast Clinical Research
Palm Harbor, Florida
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania
- Recruiting
Arizona Research Center
Phoenix, Arizona
- Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania
- Recruiting
PMG Research
Raleigh, North Carolina
- Recruiting
National Clinical Research Center
Richmond, Virginia
- Recruiting
Rochester Clinical Research
Rochester, New York
- Recruiting
Northern California Research
Sacramento, California
- Not yet recruiting
Genesis Center for Clinical Research
San Diego, California
- Recruiting
Medical Center for Clinical Research
San Diego, California
- Recruiting
Mount Vernon Clinical Research
Sandy Springs, Georgia
- Recruiting
Seattle Women's Health, Research and Gynecology
Seattle, Washington
- Recruiting
HCCA - Clinical Research Solutions
Smyrna, Tennessee
- Not yet recruiting
Tufts University
Springfield, Massachusetts
- Recruiting
Meridien Research
St. Petersburg, Florida
- Recruiting
Meridien Research
Tampa, Florida
- Recruiting
Visions Clinical Research Center
Tucson, Arizona
- Recruiting
Advanced Clinical Research
West Jordan, Utah
- Recruiting
OB/GYN Specialists of the Palm Beaches
West Palm Beach, Florida
- Recruiting
Hawthorne Medical Research
Winston-Salem, North Carolina
About this study
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
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.
Read the 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.
- Conditions
- Hot Flushes, Vasomotor Symptoms
- Being tested
- MF101 5 g/day, Placebo, MF101 10 g/day
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MF101 5 g/dayDrug
PO (orally) 5 g/day (administered twice a day, BID) for up to 12 weeks
PlaceboDrug
PO (orally) matched placebo (administered twice a day, BID) for up to 12 weeks
MF101 10 g/dayDrug
PO (orally) 10 g/day (administered twice a day, BID) for up to 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| MF101 5 g/day | Experimental | Not described Receives: Drug: MF101 5 g/day |
| MF101 10 g/day | Experimental | Not described Receives: Drug: MF101 10 g/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2009 (estimated)
- Study startOct 2011
- Primary completionFeb 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hot FlushesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bionovo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mary Tagliaferri, M.D, L.Ac., Study director, Bionovo Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00906308
- Sponsor's protocol ID
- MF-101-004
- Acronym
- HERBA
- Status last verified
- Feb 2012
- First submitted
- 19 May 2009
- Last updated
- 8 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00906308
- Acronym / sponsor ID
- HERBA / MF-101-004
- Conditions
- Hot Flushes, Vasomotor Symptoms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- BionovoIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Feb 2013 (estimated)
- First posted
- 21 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| MF101 5 g/day | Experimental | Drug: MF101 5 g/day |
| MF101 10 g/day | Experimental | Drug: MF101 10 g/day |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Confirmed postmenopausal women aged 40-65
- Provide written informed consent
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MF101 5 g/dayPO (orally) 5 g/day (administered twice a day, BID) for up to 12 weeks | Drug | MF101 5 g/day |
| PlaceboPO (orally) matched placebo (administered twice a day, BID) for up to 12 weeks | Drug | Placebo |
| MF101 10 g/dayPO (orally) 10 g/day (administered twice a day, BID) for up to 12 weeks | Drug | MF101 10 g/day |
Primary outcome
Determine the safety and efficacy of two doses of MF101 (5 g/day and 10 g/day) compared to placebo.
Time frame: 12 weeks
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jesse Langon, MPH contact
Mary Tagliaferri, M.D, L.Ac. study director
Bionovo Inc.
50 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MF101 5 g/day and MF101 10 g/day in people with Hot Flushes and Vasomotor Symptoms, run by Bionovo at 50 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jesse Langon, MPH (510-4204182), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the safety and efficacy of two doses of MF101 (5 g/day and 10 g/day) compared to placebo. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2012.