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Hormone Therapy

MF101 for Hot Flashes (HERBA Trial)

Phase 3
Waitlist Available
Research Sponsored by Bionovo
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Confirmed postmenopausal women aged 40-65
Confirmed postmenopausal women aged 40-65
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Pivotal Trial

HERBA Trial Summary

This trial will test whether MF101 is safe and effective at reducing hot flashes in postmenopausal women.

Who is the study for?
This trial is for postmenopausal women aged 40-65 who have moderate to severe hot flashes. Participants must not have a history of certain cancers, genetic mutations (BRCA1/2), or chronic liver and heart conditions. They should not be on medications that affect hormones or treat hot flashes within specific timeframes before the trial.Check my eligibility
What is being tested?
The study tests MF101's safety and effectiveness in reducing hot flash frequency in postmenopausal women. It compares two doses of MF101 (5 g/day and 10 g/day) against a placebo to see which works better.See study design
What are the potential side effects?
While the side effects are not detailed here, potential risks may include typical reactions seen with hormonal treatments such as digestive issues, changes in mood or weight, headaches, and possibly increased risk of blood clots.

HERBA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a woman aged 40-65 and have gone through menopause.
Select...
I am a woman aged 40-65 and have gone through menopause.

HERBA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determine the safety and efficacy of two doses of MF101 (5 g/day and 10 g/day) compared to placebo.

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

HERBA Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: MF101 5 g/dayExperimental Treatment1 Intervention
Group II: MF101 10 g/dayExperimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

BionovoLead Sponsor
7 Previous Clinical Trials
579 Total Patients Enrolled
2 Trials studying Hot Flashes
220 Patients Enrolled for Hot Flashes
Mary Tagliaferri, M.D, L.Ac.Study DirectorBionovo Inc.

Media Library

MF101 (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT00906308 — Phase 3
Hot Flashes Research Study Groups: MF101 5 g/day, Placebo, MF101 10 g/day
Hot Flashes Clinical Trial 2023: MF101 Highlights & Side Effects. Trial Name: NCT00906308 — Phase 3
MF101 (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00906308 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
Illinois
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Alta Bates Summit Medical Center
Medical Center for Clinical Research
Meridien Research
Other

Why did patients apply to this trial?

Symptoms of menopause. I have tried many things and nothing worked.
PatientReceived 2+ prior treatments
~90 spots leftby Feb 2025