- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00119665
Clinical Trial Assessing Toxicity and Efficacy of MF101 for Hot Flashes
May 16, 2007 updated by: Bionovo
A Phase II, Double-Blind, Placebo-Controlled, Randomized Clinical Trial Assessing Toxicity and Efficacy of MF101 for Hot Flashes and Menopausal Symptoms
The researchers propose a Phase II randomized, double-blind, placebo-controlled trial of 180 healthy postmenopausal women experiencing at least 5 hot flashes per day or 35 hot flashes per week.
Women will be randomized to one of three arms: 4.5 grams/day (dry weight of extract) of MF101, 9.0 grams/day (dry weight of extract) of MF101 or placebo for 12 weeks.
Study Overview
Study Type
Interventional
Enrollment
180
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35233
- University of Alabama At Birmingham
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California
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San Francisco, California, United States, 94118
- University of California, San Francisco
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Minnesota
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Minneapolis, Minnesota, United States, 55415
- University of Minnesota
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Tennessee
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Memphis, Tennessee, United States, 38163
- University of Tennessee Health Science Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Women between the ages of 40 to 60.
- Currently receiving medical care from a health care provider.
- Self-report 5 hot flashes per day or 35 hot flashes per week.
- Postmenopausal as defined by 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels > 30mlU/ml or 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy or hysterectomy with FSH levels > 30 mlU/ml.
- Agree not to start new herbal or dietary supplements and not to change the dose of any currently used herbal or dietary supplements for the duration of the trial.
- Successful completion of a Hot Flash Diary, a Daily Study Medication Diary and a Bleeding Diary, tolerates placebo, and 80% compliant at run-in.
- Must have had a mammogram within the last 9 months.
- Have access to a phone.
- Provide informed consent.
Exclusion Criteria:
- Inability to sign an informed consent or fill out questionnaires.
- History of breast, uterine or ovarian cancer or melanoma.
- Abnormal mammogram or breast examination within the last 9 months suggestive of cancer.
- Abnormal Pap smear or pelvic examination within the last 9 months suggestive of cancer.
- Double-wall endometrial thickness that exceeds 5 mm measured on transvaginal ultrasound.
- Unexplained abnormal uterine bleeding within six months of enrollment.
- Pregnancy or lactating.
- Clinical evidence of active ischemic cardiovascular disease or a history of cardiovascular disease.
- History of deep vein thrombosis or pulmonary embolism requiring anticoagulation.
- Active liver or gallbladder disease.
- Use of medications, herbal or dietary supplements known to possibly be effective for the treatment of hot flashes within three months of enrollment for oral or transdermal drugs, or within 6 months of enrollment for implanted or injected drugs.
- Use of raloxifene or tamoxifen within three months of enrollment.
- Use of another investigational agent within 3 months of enrollment.
- History of multiple or severe food or medicine allergies.
- Any medical or psychiatric condition that, in the investigator's opinion, would preclude the participant from adhering to the protocol or completing the trial, including severe illness, plans to move, substance abuse, significant problems, or dementia.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Frequency and severity of hot flashes
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2006
Study Completion (Actual)
February 1, 2007
Study Registration Dates
First Submitted
July 6, 2005
First Submitted That Met QC Criteria
July 6, 2005
First Posted (Estimate)
July 14, 2005
Study Record Updates
Last Update Posted (Estimate)
May 17, 2007
Last Update Submitted That Met QC Criteria
May 16, 2007
Last Verified
March 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MF-101-002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hot Flashes
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Mitsubishi Tanabe Pharma America Inc.CompletedMenopause Hot FlashesUnited States
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University of California, San FranciscoCompleted
-
University of California, San FranciscoCompleted
-
AmgenCompleted
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Alison Huang, MDNational Institute on Aging (NIA)Completed
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University of WashingtonEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedTreatment of Menopausal Hot FlashesUnited States
-
Donesta BioscienceSynteractHCRCompleted
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University of California, San FranciscoNational Center for Complementary and Integrative Health (NCCIH)CompletedHot Flashes | Hot FlushesUnited States
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National Institutes of Health Clinical Center (CC)National Cancer Institute (NCI)CompletedFever, Sweats, and Hot FlashesUnited States
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University of PennsylvaniaForest LaboratoriesCompleted
Clinical Trials on MF101
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BionovoTerminated
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BionovoUnknown
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BionovoUnknown