Hot FlashesPhase 1NCT01300078
A Clinical Trial Assessing Safety of MF101 for Hot Flushes
A Phase 1 study testing MF101 in people with Hot Flashes, run by Bionovo at 4 sites in United States.
Trial summary
This Phase 1, open label, randomized clinical trial will enroll 40 generally healthy, postmenopausal women aged 40-65 years old. Women will be randomized to one of two oral doses of MF101 for 4 weeks. Participants will be recruited at 3 clinical sites in the United States. 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 Flashes
- What is being tested?
- MF101
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 4 sitesUnited States
- Study dates
- Mar 2011to Jun 2011
- Phase
- Phase 1
- 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
- Postmenopausal women aged 40-65 years.
- Provide informed consent.
- Currently receive medical care from a health care provider. Other inclusions apply.
Who cannot join
- History of malignancy other than non-melanoma skin cancer or cervical cancer that was diagnosed and fully treated less than 5 years before screening.
- Unexplained uterine bleeding within 6 months prior to Screening.
- History of deep vein thrombosis or pulmonary embolism.
- Active liver disease or a history of impaired.
- Active gallbladder disease. Other exclusions apply.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Alta Bates, Jordan Research and Education Institute (REDI)
Berkeley, California, 94705
Clinical Trials Research
Lincoln, California, 95648
Northern California Research
Sacramento, California, 95821
Medical Center for Clinical Research
San Diego, California, 92108
About this study
Official title: A Phase 1 Open Label, Randomized Clinical Trial Assessing Safety of MF101 for Hot Flushes and Menopausal Symptoms in Postmenopausal Women
This Phase 1, open label, randomized clinical trial will enroll 40 generally healthy, postmenopausal women aged 40-65 years old. Women will be randomized to one of two oral doses of MF101 for 4 weeks. Participants will be recruited at 3 clinical sites in the United States.
Read the detailed description
MF101 is an oral, non-hormonal, botanical agent being investigated for the treatment of menopausal hot flashes.
- Conditions
- Hot Flashes
- Being tested
- MF101
- Keywords
- Hot Flashes, Hot Flushes, Vasomotor Symptoms, Menopausal Symptoms
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MF101Drug
Also called Menerba
MF101 10 g/day MF101 15 g/day
| Study group | Role | What they receive |
|---|---|---|
| MF101 10 grams/day | Experimental | Not described Receives: Drug: MF101 |
| MF101 15 grams/day | Experimental | Not described Receives: Drug: MF101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the safety of MF101, 10 g/day and 15 g/day
New or worsening abnormalities on breast, physical and general exams, laboratory measures, transvaginal ultrasound, abnormal uterine bleeding, adverse events and serious adverse events.
Measured: Randomization to 4 weeks
Secondary outcomes (1)
Compare the safety of MF101 10g/day and 15 g/day
To compare the safety of the 2 doses of MF101
Measured: Randomization to 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2011 (estimated)
- Study startMar 2011
- Primary completionJun 2011 (estimated)
- Study completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hot FlashesStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bionovo
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Wulf Utian, PhD, DSc(Med), FRCOG, FACOG, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01300078
- Sponsor's protocol ID
- MF101-008
- Status last verified
- Jun 2011
- First submitted
- 16 Feb 2011
- Last updated
- 2 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Open Label, Randomized Clinical Trial Assessing Safety of MF101 for Hot Flushes and Menopausal Symptoms in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT01300078
- Acronym / sponsor ID
- MF101-008
- Conditions
- Hot Flashes
- Keywords
- Hot Flashes, Hot Flushes, Vasomotor Symptoms, Menopausal Symptoms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- BionovoIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 21 Feb 2011 (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 1, open label, randomized clinical trial will enroll 40 generally healthy, postmenopausal women aged 40-65 years old. Women will be randomized to one of two oral doses of MF101 for 4 weeks. Participants will be recruited at 3 clinical sites in the United States.
Detailed description
MF101 is an oral, non-hormonal, botanical agent being investigated for the treatment of menopausal hot flashes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MF101 10 grams/day | Experimental | Drug: MF101 |
| MF101 15 grams/day | Experimental | Drug: MF101 |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Postmenopausal women aged 40-65 years.
- Provide informed consent.
- Currently receive medical care from a health care provider. Other inclusions apply.
Key exclusion criteria (5 listed)
- History of malignancy other than non-melanoma skin cancer or cervical cancer that was diagnosed and fully treated less than 5 years before screening.
- Unexplained uterine bleeding within 6 months prior to Screening.
- History of deep vein thrombosis or pulmonary embolism.
- Active liver disease or a history of impaired.
- Active gallbladder disease. Other exclusions apply.
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 |
|---|---|---|
| MF101Also: MenerbaMF101 10 g/day MF101 15 g/day | Drug | MF101 10 grams/day, MF101 15 grams/day |
Primary outcome
Evaluate the safety of MF101, 10 g/day and 15 g/day
Time frame: Randomization to 4 weeks
New or worsening abnormalities on breast, physical and general exams, laboratory measures, transvaginal ultrasound, abnormal uterine bleeding, adverse events and serious adverse events.
1 secondary outcome
Compare the safety of MF101 10g/day and 15 g/day
Time frame: Randomization to 4 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2011.
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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.
Wulf Utian, PhD, DSc(Med), FRCOG, FACOG principal investigator
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MF101 in people with Hot Flashes, run by Bionovo at 4 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 3 inclusion and 5 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 2 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the safety of MF101, 10 g/day and 15 g/day (time frame: Randomization to 4 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 2 Jun 2011.