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A Clinical Trial Assessing Safety of MF101 for Hot Flushes

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ClinicalTrials.gov Identifier: NCT01300078
Recruitment Status : Unknown
Verified June 2011 by Bionovo.
Recruitment status was:  Active, not recruiting
First Posted : February 21, 2011
Last Update Posted : June 2, 2011
Sponsor:
Information provided by:
Bionovo

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hot Flashes Drug: MF101 Phase 1

Detailed Description:
MF101 is an oral, non-hormonal, botanical agent being investigated for the treatment of menopausal hot flashes.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Open Label, Randomized Clinical Trial Assessing Safety of MF101 for Hot Flushes and Menopausal Symptoms in Postmenopausal Women
Study Start Date : March 2011
Estimated Primary Completion Date : June 2011
Estimated Study Completion Date : June 2011

Arm Intervention/treatment
Experimental: MF101 10 grams/day Drug: MF101
MF101 10 g/day MF101 15 g/day
Other Name: Menerba

Experimental: MF101 15 grams/day Drug: MF101
MF101 10 g/day MF101 15 g/day
Other Name: Menerba




Primary Outcome Measures :
  1. Evaluate the safety of MF101, 10 g/day and 15 g/day [ Time Frame: Randomization to 4 weeks ]
    New or worsening abnormalities on breast, physical and general exams, laboratory measures, transvaginal ultrasound, abnormal uterine bleeding, adverse events and serious adverse events.


Secondary Outcome Measures :
  1. Compare the safety of MF101 10g/day and 15 g/day [ Time Frame: Randomization to 4 Weeks ]
    To compare the safety of the 2 doses of MF101



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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01300078


Locations
United States, California
Alta Bates, Jordan Research and Education Institute (REDI)
Berkeley, California, United States, 94705
Clinical Trials Research
Lincoln, California, United States, 95648
Northern California Research
Sacramento, California, United States, 95821
Medical Center for Clinical Research
San Diego, California, United States, 92108
Sponsors and Collaborators
Bionovo
Investigators
Principal Investigator: Wulf Utian, PhD, DSc(Med), FRCOG, FACOG

Responsible Party: Mary Tagliaferri, MD, LAc/President and CMO, Bionovo
ClinicalTrials.gov Identifier: NCT01300078     History of Changes
Other Study ID Numbers: MF101-008
First Posted: February 21, 2011    Key Record Dates
Last Update Posted: June 2, 2011
Last Verified: June 2011

Keywords provided by Bionovo:
Hot Flashes
Hot Flushes
Vasomotor Symptoms
Menopausal Symptoms

Additional relevant MeSH terms:
Hot Flashes
Signs and Symptoms