Back to resultsBlack Cohosh Extract in Postmenopausal Breast Health
Primary Purpose
Menopause, Hot Flashes
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Black Cohosh Extract (BCE)
Sponsored by
About this trial
This is an interventional prevention trial for Menopause focused on measuring estrogen stimulation, relief of hot flashes, nipple aspirate fluid, body fluid levels of black cohosh
Eligibility Criteria
Postmenopausal females 20 months since any breastfeeding Active postmenopausal symptoms, i.e., hot flashes At least 6 months since last menstrual period or have had a hysterectomy with both ovaries removed Able to make 4 visits during the trial to the study clinic in Columbia, Missouri
Sites / Locations
- University of Missouri-Columbia
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00064831
First Posted
July 14, 2003
Last Updated
December 6, 2007
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborators
University of Missouri-Columbia
1. Study Identification
Unique Protocol Identification Number
NCT00064831
Brief Title
Black Cohosh Extract in Postmenopausal Breast Health
Official Title
The Effect of Black Cohosh Extract on the Human Breast
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborators
University of Missouri-Columbia
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of the study is to determine if black cohosh extract (BCE) administration in symptomatic postmenopausal women results in estrogenic stimulation of the breast, as determined by estradiol, pS2, FSH, LH, and PSA levels in nipple aspirate fluid.
Detailed Description
As in Brief Summary
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menopause, Hot Flashes
Keywords
estrogen stimulation, relief of hot flashes, nipple aspirate fluid, body fluid levels of black cohosh
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
73 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Black Cohosh Extract (BCE)
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Postmenopausal females
20 months since any breastfeeding
Active postmenopausal symptoms, i.e., hot flashes
At least 6 months since last menstrual period or have had a hysterectomy with both ovaries removed
Able to make 4 visits during the trial to the study clinic in Columbia, Missouri
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward Sauter, MD
Organizational Affiliation
University of Missouri-Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Missouri-Columbia
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
12. IPD Sharing Statement
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Black Cohosh Extract in Postmenopausal Breast Health
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