A Clinical Trial Assessing Safety of MF101 for Hot Flushes
- Registration Number
- NCT01300078
- Lead Sponsor
- Bionovo
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 40
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MF101 15 grams/day MF101 - MF101 10 grams/day MF101 -
- Primary Outcome Measures
Name Time Method Evaluate the safety of MF101, 10 g/day and 15 g/day 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.
- Secondary Outcome Measures
Name Time Method Compare the safety of MF101 10g/day and 15 g/day Randomization to 4 Weeks To compare the safety of the 2 doses of MF101
Trial Locations
- Locations (4)
Medical Center for Clinical Research
🇺🇸San Diego, California, United States
Clinical Trials Research
🇺🇸Lincoln, California, United States
Northern California Research
🇺🇸Sacramento, California, United States
Alta Bates, Jordan Research and Education Institute (REDI)
🇺🇸Berkeley, California, United States