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MF101 for Hot Flashes (HERBA Trial)
HERBA Trial Summary
This trial will test whether MF101 is safe and effective at reducing hot flashes in postmenopausal women.
HERBA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowHERBA Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.HERBA Trial Design
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Who is running the clinical trial?
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- I carry the BRCA1 or BRCA2 gene mutation.I have had cancer before, but it was not skin or cervical cancer.I have abnormal growths in my uterus, but not fibroids.I have heart disease, high blood pressure, or a history of strokes or mini-strokes.I have stopped taking certain hormone therapies or antidepressants as required.My recent mammogram or breast exam suggested cancer.I have a history of blood clots, severe bowel issues, or unexplained weight loss.I have stopped any medications or supplements for hot flushes or those affecting hormones as required.I am a woman aged 40-65 and have gone through menopause.I have an active liver or gall bladder disease.I regularly use morphine or similar painkillers.I have a history of chronic hepatitis or HIV.
- Group 1: MF101 5 g/day
- Group 2: Placebo
- Group 3: MF101 10 g/day
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Do the participants of this clinical trial have to be over 25 years old?
"The age limit for participants in this research study is between 40 and 65 years old."
At how many different hospitals is this research project being conducted?
"There are a total of 50 different sites conducting this research, but the three primary locations are Advanced Clinical Research in Boise, Idaho; Meridien Research in St. Petersburg, New jersey; and Robert Wood Johnson University Hospital in New Brunswick, Virginia."
What does the FDA have to say about MF101 5 g/day dosage?
"MF101 5 g/day has received a safety score of 3. This is due to the medication being in Phase 3 trials, which suggests that not only is there some evidence supporting its efficacy, but also that there have been multiple rounds of testing affirming its safety."
How many participants are being included in this clinical research?
"Unfortunately, this particular trial is not presently recruiting any more patients. However, the study was last edited on 2/6/2012 and might open up recruitment in the future. There are other active trials enrolling participants with hot flashes (32 clinical trials) and 1 trial for MF101 5 g/day that may be of interest."
Are there any inclusionary or exclusionary criteria for this research?
"This study is looking for 1200 post-menopausal women, aged 40 to 65 years old, who experience hot flashes. In addition to these inclusion criteria, individuals must also be willing and able to provide informed consent."
What is the scientific literature landscape like for MF101 5 g/day?
"MF101 5 g/day was first studied in 2011 by Suncoast Clinical Research. So far, there have been 18289 completed studies and 1 active clinical trial recruiting patients. A majority of these trials are being conducted out of Boise, Idaho."
What makes this trial unique compared to others?
"MF101 5 g/day has been under investigation since 2011 when the first trial, sponsored by Bionovo, took place. After the initial study involving 1200 people was completed in 2011, MF101 5 g/day entered Phase 3 of clinical trials. As of now, there is one active study being conducted on the medication and it is again sponsored by Bionovo."
Are we still looking for volunteers for this research project?
"Unfortunately, this particular trial is not currently looking for new patients. The listing was first posted on October 1st 2011 and last updated February 6th 2012. If you are interested in other studies, there are presently 32 trials actively enrolling patients with hot flashes and 1 study for MF101 5 g/day admitting patients."
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