Back to resultsA Study of the Pharmacokinetics of Black Cohosh
Primary Purpose
Hot Flashes
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Black cohosh
Sponsored by
About this trial
This is an interventional treatment trial for Hot Flashes focused on measuring Black cohosh, Pharmacokinetics, Alternative therapies, Natural product
Eligibility Criteria
Inclusion Criteria: No prior diagnosis of cancer other than non-melanoma skin cancer or carcinoma in-situ of the cervix No current prescription medication use Negative urine pregnancy test OR greater than age 50 with no menses for at least one year OR documented status post hysterectomy Competent to understand and sign informed consent
Sites / Locations
- Duke University Medical Center
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00068185
First Posted
September 9, 2003
Last Updated
December 9, 2009
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT00068185
Brief Title
A Study of the Pharmacokinetics of Black Cohosh
Official Title
Interactions Between SERMs, Soy and Black Cohosh
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Terminated
Why Stopped
PI left institution, study did not continue, funding stopped
Study Start Date
August 2003 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Black cohosh is a natural supplement that has been used to treat and prevent menopausal symptoms. Remifemin is a standardized form of black cohosh. The purpose of this study is to determine the levels of components of black cohosh obtained in the blood of healthy women taking Remifemin.
Detailed Description
As per Brief Summary
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hot Flashes
Keywords
Black cohosh, Pharmacokinetics, Alternative therapies, Natural product
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Black cohosh
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
No prior diagnosis of cancer other than non-melanoma skin cancer or carcinoma in-situ of the cervix
No current prescription medication use
Negative urine pregnancy test OR greater than age 50 with no menses for at least one year OR documented status post hysterectomy
Competent to understand and sign informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather S Shaw, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of the Pharmacokinetics of Black Cohosh
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