Clinical Trial Assessing Toxicity and Efficacy of MF101 for Hot Flashes

This study has been completed.
Sponsor:
Information provided by:
Bionovo
ClinicalTrials.gov Identifier:
NCT00119665
First received: July 6, 2005
Last updated: May 16, 2007
Last verified: March 2007
  Purpose

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.


Condition Intervention Phase
Hot Flashes
Drug: MF101
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase II, Double-Blind, Placebo-Controlled, Randomized Clinical Trial Assessing Toxicity and Efficacy of MF101 for Hot Flashes and Menopausal Symptoms

Further study details as provided by Bionovo:

Primary Outcome Measures:
  • Frequency and severity of hot flashes

Estimated Enrollment: 180
Study Start Date: February 2006
Study Completion Date: February 2007
  Eligibility

Ages Eligible for Study:   40 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00119665

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
United States, California
University of California, San Francisco
San Francisco, California, United States, 94118
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55415
United States, Tennessee
University of Tennessee Health Science Center
Memphis, Tennessee, United States, 38163
Sponsors and Collaborators
Bionovo
Investigators
Principal Investigator: Deborah Grady, MD, MPH University of California, San Francisco
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00119665     History of Changes
Other Study ID Numbers: MF-101-002
Study First Received: July 6, 2005
Last Updated: May 16, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Bionovo:
Postmenopausal symptoms
Hot Flashes
Postmenopausal Hot Flashes

Additional relevant MeSH terms:
Hot Flashes
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014