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A Clinical Trial Assessing Safety of MF101 for Hot Flushes

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Bionovo
ClinicalTrials.gov Identifier:
NCT01300078
First received: February 16, 2011
Last updated: June 1, 2011
Last verified: June 2011
History of Changes
  Purpose

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 Intervention Phase
Hot Flashes
 Drug: MF101
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Menopause
U.S. FDA Resources

Further study details as provided by Bionovo:

Primary Outcome Measures:
  • Evaluate the safety of MF101, 10 g/day and 15 g/day [ Time Frame: Randomization to 4 weeks ] [ Designated as safety issue: Yes ]
    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:
  • Compare the safety of MF101 10g/day and 15 g/day [ Time Frame: Randomization to 4 Weeks ] [ Designated as safety issue: Yes ]
    To compare the safety of the 2 doses of MF101


Estimated Enrollment: 40
Study Start Date: March 2011
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Mary Tagliaferri, MD, LAc/President and CMO, Bionovo
ClinicalTrials.gov Identifier: NCT01300078     History of Changes
Other Study ID Numbers: MF101-008
Study First Received: February 16, 2011
Last Updated: June 1, 2011
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Hot Flashes
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013