A Clinical Trial Assessing Safety of MF101 for Hot Flushes
A Phase 1 Open Label, Randomized Clinical Trial Assessing Safety of MF101 for Hot Flushes and Menopausal Symptoms in Postmenopausal Women
1 other identifier
interventional
40
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Mar 2011
Shorter than P25 for phase_1
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 16, 2011
CompletedFirst Posted
Study publicly available on registry
February 21, 2011
CompletedStudy Start
First participant enrolled
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedJune 2, 2011
June 1, 2011
3 months
February 16, 2011
June 1, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Randomization to 4 weeks
Secondary Outcomes (1)
Compare the safety of MF101 10g/day and 15 g/day
Randomization to 4 Weeks
Study Arms (2)
MF101 10 grams/day
EXPERIMENTALMF101 15 grams/day
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Postmenopausal women aged 40-65 years.
- Provide informed consent.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bionovolead
Study Sites (4)
Alta Bates, Jordan Research and Education Institute (REDI)
Berkeley, California, 94705, United States
Clinical Trials Research
Lincoln, California, 95648, United States
Northern California Research
Sacramento, California, 95821, United States
Medical Center for Clinical Research
San Diego, California, 92108, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wulf Utian, PhD, DSc(Med), FRCOG, FACOG
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 16, 2011
First Posted
February 21, 2011
Study Start
March 1, 2011
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
June 2, 2011
Record last verified: 2011-06