Status:
UNKNOWN
A Study of MF101 in Postmenopausal Women
Lead Sponsor:
Bionovo
Conditions:
Hot Flushes
Vasomotor Symptoms
Eligibility:
FEMALE
40-65 years
Phase:
PHASE3
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; ho...
Eligibility Criteria
Inclusion
- Inclusion Criteria (limited):
- Confirmed postmenopausal women aged 40-65
- Provide written informed consent
- Exclusion Criteria (limited):
- History of malignancy, with the exception of certain types of skin cancer or cervical cancer
- Known carrier of BRCA1 or BRCA2
- Abnormal mammogram or breast examination suggestive of cancer within 9 months of screening
- Endometrial hyperplasia, polyps or abnormal uterine masses (with the exception of fibroids)
- Clinical evidence of active ischemic heart disease, history of cardiovascular disease, uncontrolled hypertension, or a history of transient ischemic attacks or cerebrovascular accidents
- History of deep vein thrombosis, pulmonary embolism, severe chronic diarrhea, chronic constipation, uncontrolled inflammatory bowel syndrome or disease (IBS or IBD), or unexplained weight loss
- Active liver disease or gall bladder disease
- History of chronic hepatitis B, hepatitis C, hepatitis within 3 months, or HIV infection
- Use of prescription medications or herbal/dietary supplements for the treatment of hot flushes or those with known estrogenic/progestogenic activity within required wash-out timeframes
- Use of selective receptor modulators (SERMs), aromatase inhibitors, gonadotropin-releasing hormone agonists, selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs), gabapentin or clonidine within required wash-out timeframes
- Chronic use of morphine or other opiates
Exclusion
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT00906308
Start Date
October 1 2011
Last Update
February 8 2012
Active Locations (50)
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1
Arizona Research Center
Phoenix, Arizona, United States
2
Visions Clinical Research Center
Tucson, Arizona, United States
3
Alta Bates Summit Medical Center
Berkeley, California, United States
4
Northern California Research
Sacramento, California, United States