Back to resultsA Clinical Trial Assessing Safety of MF101 for Hot Flushes
Primary Purpose
Hot Flashes
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MF101
Sponsored by
About this trial
This is an interventional treatment trial for Hot Flashes focused on measuring Hot Flashes, Hot Flushes, Vasomotor Symptoms, Menopausal Symptoms
Eligibility Criteria
Inclusion Criteria (partial list):
- Postmenopausal women aged 40-65 years.
- Provide informed consent.
- Currently receive medical care from a health care provider. Other inclusions apply.
Exclusion Criteria (partial list):
- 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.
Sites / Locations
- Alta Bates, Jordan Research and Education Institute (REDI)
- Clinical Trials Research
- Northern California Research
- Medical Center for Clinical Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
MF101 10 grams/day
MF101 15 grams/day
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Compare the safety of MF101 10g/day and 15 g/day
To compare the safety of the 2 doses of MF101
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01300078
Brief Title
A Clinical Trial Assessing Safety of MF101 for Hot Flushes
Official Title
A Phase 1 Open Label, Randomized Clinical Trial Assessing Safety of MF101 for Hot Flushes and Menopausal Symptoms in Postmenopausal Women
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Unknown status
Study Start Date
March 2011 (undefined)
Primary Completion Date
June 2011 (Anticipated)
Study Completion Date
June 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Bionovo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed Description
MF101 is an oral, non-hormonal, botanical agent being investigated for the treatment of menopausal hot flashes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hot Flashes
Keywords
Hot Flashes, Hot Flushes, Vasomotor Symptoms, Menopausal Symptoms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MF101 10 grams/day
Arm Type
Experimental
Arm Title
MF101 15 grams/day
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
MF101
Other Intervention Name(s)
Menerba
Intervention Description
MF101 10 g/day MF101 15 g/day
Primary Outcome Measure Information:
Title
Evaluate the safety of MF101, 10 g/day and 15 g/day
Description
New or worsening abnormalities on breast, physical and general exams, laboratory measures, transvaginal ultrasound, abnormal uterine bleeding, adverse events and serious adverse events.
Time Frame
Randomization to 4 weeks
Secondary Outcome Measure Information:
Title
Compare the safety of MF101 10g/day and 15 g/day
Description
To compare the safety of the 2 doses of MF101
Time Frame
Randomization to 4 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 (partial list):
Postmenopausal women aged 40-65 years.
Provide informed consent.
Currently receive medical care from a health care provider. Other inclusions apply.
Exclusion Criteria (partial list):
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wulf Utian, PhD, DSc(Med), FRCOG, FACOG
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alta Bates, Jordan Research and Education Institute (REDI)
City
Berkeley
State/Province
California
ZIP/Postal Code
94705
Country
United States
Facility Name
Clinical Trials Research
City
Lincoln
State/Province
California
ZIP/Postal Code
95648
Country
United States
Facility Name
Northern California Research
City
Sacramento
State/Province
California
ZIP/Postal Code
95821
Country
United States
Facility Name
Medical Center for Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Clinical Trial Assessing Safety of MF101 for Hot Flushes
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