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.
MF101 is an oral, non-hormonal, botanical agent being investigated for the treatment of menopausal hot flashes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
MF101 10 g/day MF101 15 g/day
Alta Bates, Jordan Research and Education Institute (REDI)
Berkeley, California, United States
Clinical Trials Research
Lincoln, California, United States
Northern California Research
Sacramento, California, United States
Medical Center for Clinical Research
San Diego, California, United States
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.
Time frame: Randomization to 4 weeks
Compare the safety of MF101 10g/day and 15 g/day
To compare the safety of the 2 doses of MF101
Time frame: Randomization to 4 Weeks
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