Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2025-12-31 @ 12:31 PM
Study NCT ID:
NCT00906308
Status:
UNKNOWN
Last Update Posted:
2012-02-08
First Post:
2009-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of MF101 in Postmenopausal Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019584', 'term': 'Hot Flashes'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'lastUpdateSubmitDate': '2012-02-06', 'studyFirstSubmitDate': '2009-05-19', 'studyFirstSubmitQcDate': '2009-05-20', 'lastUpdatePostDateStruct': {'date': '2012-02-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine the safety and efficacy of two doses of MF101 (5 g/day and 10 g/day) compared to placebo.', 'timeFrame': '12 weeks', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Hot Flushes', 'Vasomotor Symptoms']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mf101.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nMF101, 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria (limited):\n\n* Confirmed postmenopausal women aged 40-65\n* Provide written informed consent\n\nExclusion Criteria (limited):\n\n* History of malignancy, with the exception of certain types of skin cancer or cervical cancer\n* Known carrier of BRCA1 or BRCA2\n* Abnormal mammogram or breast examination suggestive of cancer within 9 months of screening\n* Endometrial hyperplasia, polyps or abnormal uterine masses (with the exception of fibroids)\n* Clinical evidence of active ischemic heart disease, history of cardiovascular disease, uncontrolled hypertension, or a history of transient ischemic attacks or cerebrovascular accidents\n* 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\n* Active liver disease or gall bladder disease\n* History of chronic hepatitis B, hepatitis C, hepatitis within 3 months, or HIV infection\n* 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\n* 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\n* Chronic use of morphine or other opiates'}, 'identificationModule': {'nctId': 'NCT00906308', 'acronym': 'HERBA', 'briefTitle': 'A Study of MF101 in Postmenopausal Women', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bionovo'}, 'officialTitle': 'A Phase 3, Double-blind, Placebo-Controlled, Randomized Clinical Trial, Assessing Safety and Efficacy of MF101 for Hot Flushes and Menopausal Symptoms in Postmenopausal Women', 'orgStudyIdInfo': {'id': 'MF-101-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'MF101 5 g/day', 'interventionNames': ['Drug: MF101 5 g/day']}, {'type': 'EXPERIMENTAL', 'label': 'MF101 10 g/day', 'interventionNames': ['Drug: MF101 10 g/day']}], 'interventions': [{'name': 'MF101 5 g/day', 'type': 'DRUG', 'description': 'PO (orally) 5 g/day (administered twice a day, BID) for up to 12 weeks', 'armGroupLabels': ['MF101 5 g/day']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'PO (orally) matched placebo (administered twice a day, BID) for up to 12 weeks', 'armGroupLabels': ['Placebo']}, {'name': 'MF101 10 g/day', 'type': 'DRUG', 'description': 'PO (orally) 10 g/day (administered twice a day, BID) for up to 12 weeks', 'armGroupLabels': ['MF101 10 g/day']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Phoenix', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Arizona Research Center', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'city': 'Tucson', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Visions Clinical Research Center', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'city': 'Berkeley', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Alta Bates Summit Medical Center', 'geoPoint': {'lat': 37.87159, 'lon': -122.27275}}, {'city': 'Sacramento', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Northern California Research', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'city': 'San Diego', 'state': 'California', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Genesis Center for Clinical Research', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'city': 'San Diego', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Medical Center for Clinical Research', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'city': 'Denver', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'facility': "Downtown Women's Health Care", 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'city': 'Boynton Beach', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Visions Clinical Research', 'geoPoint': {'lat': 26.52535, 'lon': -80.06643}}, {'city': 'Bradenton', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Meridien Research', 'geoPoint': {'lat': 27.49893, 'lon': -82.57482}}, {'city': 'Brooksville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Meridien Research', 'geoPoint': {'lat': 28.55554, 'lon': -82.38991}}, {'city': 'New Port Richey', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Suncoast Clinical Research', 'geoPoint': {'lat': 28.24418, 'lon': -82.71927}}, {'city': 'Orlando', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Compass Research', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'city': 'Palm Harbor', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Suncoast Clinical Research', 'geoPoint': {'lat': 28.07807, 'lon': -82.76371}}, {'city': 'St. Petersburg', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Meridien Research', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'city': 'Tampa', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Meridien Research', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'city': 'West Palm Beach', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'OB/GYN Specialists of the Palm Beaches', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'city': 'Decatur', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Soapstone Center for Clinical Research', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'city': 'Sandy Springs', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Mount Vernon Clinical Research', 'geoPoint': {'lat': 33.92427, 'lon': -84.37854}}, {'city': 'Boise', 'state': 'Idaho', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Advanced Clinical Research', 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}, {'city': 'Baltimore', 'state': 'Maryland', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'city': 'Springfield', 'state': 'Massachusetts', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Tufts University', 'geoPoint': {'lat': 42.10148, 'lon': -72.58981}}, {'city': 'New Brunswick', 'state': 'New Jersey', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Robert Wood Johnson University Hospital', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'city': 'Albuquerque', 'state': 'New Mexico', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Albuquerque Clinical Trials', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'city': 'Albuquerque', 'state': 'New Mexico', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'New Mexico Clinical Research & Osteoporosis Center', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'city': 'Rochester', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Rochester Clinical Research', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'city': 'New Bern', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': "Eastern Carolina Women's Center", 'geoPoint': {'lat': 35.10849, 'lon': -77.04411}}, {'city': 'Raleigh', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'PMG Research', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'city': 'Winston-Salem', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Hawthorne Medical Research', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'city': 'Cleveland', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Rapid Medical Research', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'city': 'Columbus', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'facility': "Columbus Center for Women's Health Research", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'city': 'Eugene', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Clinical Trials of America', 'geoPoint': {'lat': 44.05207, 'lon': -123.08675}}, {'city': 'Medford', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'facility': "Advanced Clinical Research - A Division of Medford Women's Clinic", 'geoPoint': {'lat': 42.32652, 'lon': -122.87559}}, {'city': 'Jenkintown', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'The Clinical Trial Center', 'geoPoint': {'lat': 40.09594, 'lon': -75.12517}}, {'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'city': 'Pittsburgh', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'city': 'Columbia', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'South Carolina Clinical Research', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}, {'city': 'Mt. Pleasant', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Coastal Carolina Research Center', 'geoPoint': {'lat': 32.79407, 'lon': -79.86259}}, {'city': 'Franklin', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'HCCA - Clinical Research Solutions', 'geoPoint': {'lat': 35.92506, 'lon': -86.86889}}, {'city': 'Jackson', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'HCCA - Clinical Research Solutions', 'geoPoint': {'lat': 35.61452, 'lon': -88.81395}}, {'city': 'Memphis', 'state': 'Tennessee', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'University of Tennessee at Memphis', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'city': 'Smyrna', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'HCCA - Clinical Research Solutions', 'geoPoint': {'lat': 35.98284, 'lon': -86.5186}}, {'city': 'Austin', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Benchmark Research', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'city': 'Austin', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Women Partners in Health/Professional Quality Research', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'city': 'Dallas', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Discovery Clinical Trials', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'city': 'Lake Jackson', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'R/D Clinical Research', 'geoPoint': {'lat': 29.03386, 'lon': -95.43439}}, {'city': 'West Jordan', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Advanced Clinical Research', 'geoPoint': {'lat': 40.60967, 'lon': -111.9391}}, {'city': 'Charlottesville', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Virginia', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'city': 'Norfolk', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'National Clinical Research', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'city': 'Richmond', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'National Clinical Research Center', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'city': 'Seattle', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'facility': "Seattle Women's Health, Research and Gynecology", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'centralContacts': [{'name': 'Jesse Langon, MPH', 'role': 'CONTACT', 'phone': '510-4204182'}], 'overallOfficials': [{'name': 'Mary Tagliaferri, M.D, L.Ac.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bionovo Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bionovo', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}