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Clinical Trial Assessing Toxicity and Efficacy of MF101 for Hot Flashes

Primary Purpose

Hot Flashes

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
MF101
Sponsored by
Bionovo
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hot Flashes focused on measuring Postmenopausal symptoms, Hot Flashes, Postmenopausal Hot Flashes

Eligibility Criteria

40 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Alabama at Birmingham
  • University of California, San Francisco
  • University of Minnesota
  • University of Tennessee Health Science Center

Outcomes

Primary Outcome Measures

Frequency and severity of hot flashes

Secondary Outcome Measures

Full Information

First Posted
July 6, 2005
Last Updated
May 16, 2007
Sponsor
Bionovo
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1. Study Identification

Unique Protocol Identification Number
NCT00119665
Brief Title
Clinical Trial Assessing Toxicity and Efficacy of MF101 for Hot Flashes
Official Title
A Phase II, Double-Blind, Placebo-Controlled, Randomized Clinical Trial Assessing Toxicity and Efficacy of MF101 for Hot Flashes and Menopausal Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bionovo

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hot Flashes
Keywords
Postmenopausal symptoms, Hot Flashes, Postmenopausal Hot Flashes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
180 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
MF101
Primary Outcome Measure Information:
Title
Frequency and severity of hot flashes

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah Grady, MD, MPH
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Facility Name
University of Tennessee Health Science Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38163
Country
United States

12. IPD Sharing Statement

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Clinical Trial Assessing Toxicity and Efficacy of MF101 for Hot Flashes

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