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A 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
National Center for Complementary and Integrative Health (NCCIH)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hot Flashes focused on measuring Black cohosh, Pharmacokinetics, Alternative therapies, Natural product

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

First Posted
September 9, 2003
Last Updated
December 9, 2009
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
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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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