A Study of MF101 in Postmenopausal Women
- Conditions
- Hot FlushesVasomotor Symptoms
- Interventions
- Registration Number
- NCT00906308
- Lead Sponsor
- Bionovo
- Brief Summary
This phase 3a study is designed to assess the safety and efficacy of MF101 on the frequency of moderate to severe hot flushes in postmenopausal women.
- Detailed Description
Menopausal women often experience debilitating menopausal vasomotor symptoms and associated insomnia. Until recently, vasomotor symptoms were often treated with estrogens, which are very effective; however, randomized clinical trials have shown that postmenopausal combination hormone therapy increases the risks for stroke, cardiovascular events, and breast cancer. New, more effective, and safer treatments for menopausal vasomotor symptoms are therefore needed.
MF101, a botanical extract, is a non-hormonal investigational treatment being tested in a randomized, double-blind, placebo-controlled phase 3a clinical trial to assess the safety and efficacy of MF101 on the frequency of moderate to severe hot flushes in postmenopausal women. Approximately 1200 healthy post-menopausal women, aged 40-65, with moderate to severe hot flushes will be enrolled to determine the safety and efficacy of two doses of MF101 (5 g/day and 10 g/day) compared to placebo after 12 weeks of treatment.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 1200
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - MF101 5 g/day MF101 5 g/day - MF101 10 g/day MF101 10 g/day -
- Primary Outcome Measures
Name Time Method Determine the safety and efficacy of two doses of MF101 (5 g/day and 10 g/day) compared to placebo. 12 weeks Safety will be measured through clinically significant findings in physical examinations, laboratory parameters, endometrial changes, abnormal uterine bleeding and any other adverse events. Efficacy will be measured by the mean change in frequency of moderate to severe hot flushes from baseline to treatment week 12.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (43)
Clinical Trials of America
🇺🇸Eugene, Oregon, United States
Soapstone Center for Clinical Research
🇺🇸Decatur, Georgia, United States
Northern California Research
🇺🇸Sacramento, California, United States
PMG Research
🇺🇸Raleigh, North Carolina, United States
New Mexico Clinical Research & Osteoporosis Center
🇺🇸Albuquerque, New Mexico, United States
Suncoast Clinical Research
🇺🇸Palm Harbor, Florida, United States
Visions Clinical Research Center
🇺🇸Tucson, Arizona, United States
Alta Bates Summit Medical Center
🇺🇸Berkeley, California, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
Coastal Carolina Research Center
🇺🇸Mt. Pleasant, South Carolina, United States
Benchmark Research
🇺🇸Austin, Texas, United States
National Clinical Research
🇺🇸Norfolk, Virginia, United States
Discovery Clinical Trials
🇺🇸Dallas, Texas, United States
Arizona Research Center
🇺🇸Phoenix, Arizona, United States
Genesis Center for Clinical Research
🇺🇸San Diego, California, United States
Medical Center for Clinical Research
🇺🇸San Diego, California, United States
Columbus Center for Women's Health Research
🇺🇸Columbus, Ohio, United States
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Seattle Women's Health, Research and Gynecology
🇺🇸Seattle, Washington, United States
Downtown Women's Health Care
🇺🇸Denver, Colorado, United States
Meridien Research
🇺🇸Tampa, Florida, United States
Visions Clinical Research
🇺🇸Boynton Beach, Florida, United States
Mount Vernon Clinical Research
🇺🇸Sandy Springs, Georgia, United States
Albuquerque Clinical Trials
🇺🇸Albuquerque, New Mexico, United States
R/D Clinical Research
🇺🇸Lake Jackson, Texas, United States
The Clinical Trial Center
🇺🇸Jenkintown, Pennsylvania, United States
National Clinical Research Center
🇺🇸Richmond, Virginia, United States
HCCA - Clinical Research Solutions
🇺🇸Smyrna, Tennessee, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Advanced Clinical Research
🇺🇸West Jordan, Utah, United States
Hawthorne Medical Research
🇺🇸Winston-Salem, North Carolina, United States
Compass Research
🇺🇸Orlando, Florida, United States
OB/GYN Specialists of the Palm Beaches
🇺🇸West Palm Beach, Florida, United States
Rochester Clinical Research
🇺🇸Rochester, New York, United States
Robert Wood Johnson University Hospital
🇺🇸New Brunswick, New Jersey, United States
Rapid Medical Research
🇺🇸Cleveland, Ohio, United States
South Carolina Clinical Research
🇺🇸Columbia, South Carolina, United States
University of Tennessee at Memphis
🇺🇸Memphis, Tennessee, United States
Eastern Carolina Women's Center
🇺🇸New Bern, North Carolina, United States
Advanced Clinical Research - A Division of Medford Women's Clinic
🇺🇸Medford, Oregon, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Women Partners in Health/Professional Quality Research
🇺🇸Austin, Texas, United States
Tufts University
🇺🇸Springfield, Massachusetts, United States