A Study of the Pharmacokinetics of Black Cohosh - Full Text View

A Study of the Pharmacokinetics of Black Cohosh

This study has been completed.

Sponsored by:	National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:	National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:	NCT00068185

Purpose

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.

Condition	Intervention	Phase
Hot Flashes	Drug: Black cohosh	Phase I

Drug Information available for:

Proteins, soy

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study

Official Title:	Interactions Between SERMs, Soy and Black Cohosh

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Estimated Enrollment:	12
Study Start Date:	August 2003
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Detailed Description:

As per Brief Summary

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00068185

Locations


United States, North Carolina
	Duke University Medical Center
	Durham, North Carolina, United States, 27710

Sponsors and Collaborators

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators


Principal Investigator:	Heather S Shaw, MD	Duke University

More Information

Responsible Party:	Duke University ( Heather Shaw, MD )
Study ID Numbers:	K08 AT001315-01A1
First Received:	September 9, 2003
Last Updated:	August 11, 2008
ClinicalTrials.gov Identifier:	NCT00068185
Health Authority:	United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):

Black cohosh

Pharmacokinetics

Alternative therapies

Natural product

Study placed in the following topic categories:

Signs and Symptoms

Hot Flashes

ClinicalTrials.gov processed this record on November 20, 2008