A Clinical Trial Assessing Safety of MF101 for Hot Flushes
This trial is active, not recruiting.
|Start date||March 2011|
|End date||June 2011|
|Trial size||40 participants|
|Trial identifier||NCT01300078, MF101-008|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Berkeley, CA||Alta Bates, Jordan Research and Education Institute (REDI)||no longer recruiting|
|Lincoln, CA||Clinical Trials Research||no longer recruiting|
|Sacramento, CA||Northern California Research||no longer recruiting|
|San Diego, CA||Medical Center for Clinical Research||no longer recruiting|
|Endpoint classification||safety study|
|Intervention model||parallel assignment|
Evaluate the safety of MF101, 10 g/day and 15 g/day
time frame: Randomization to 4 weeks
Compare the safety of MF101 10g/day and 15 g/day
time frame: Randomization to 4 Weeks
Female participants from 40 years up to 65 years old.
Inclusion Criteria (partial list): - Postmenopausal women aged 40-65 years. - Provide informed consent. - Currently receive medical care from a health care provider. Other inclusions apply. Exclusion Criteria (partial list): - History of malignancy other than non-melanoma skin cancer or cervical cancer that was diagnosed and fully treated less than 5 years before screening. - Unexplained uterine bleeding within 6 months prior to Screening. - History of deep vein thrombosis or pulmonary embolism. - Active liver disease or a history of impaired. - Active gallbladder disease. Other exclusions apply.
|Official title||A Phase 1 Open Label, Randomized Clinical Trial Assessing Safety of MF101 for Hot Flushes and Menopausal Symptoms in Postmenopausal Women|
|Principal investigator||Wulf Utian, PhD, DSc(Med), FRCOG, FACOG|
|Description||MF101 is an oral, non-hormonal, botanical agent being investigated for the treatment of menopausal hot flashes.|
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