A Study of the Pharmacokinetics of Black Cohosh

This study has been terminated.

(PI left institution, study did not continue, funding stopped)

Sponsor:

Information provided by:

National Center for Complementary and Integrative Health (NCCIH)

ClinicalTrials.gov Identifier:

NCT00068185

First received: September 9, 2003

Last updated: December 9, 2009

Last verified: December 2009

History of Changes

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 1


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Interactions Between SERMs, Soy and Black Cohosh

Resource links provided by NLM:

Drug Information available for: Cimicifuga racemosa extract

U.S. FDA Resources

Further study details as provided by National Center for Complementary and Integrative Health (NCCIH):


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Integrative Health (NCCIH)

Investigators


Principal Investigator:	Heather S Shaw, MD	Duke University

More Information

No publications provided


Responsible Party:	Heather Shaw, MD, Duke University
ClinicalTrials.gov Identifier:	NCT00068185 History of Changes
Other Study ID Numbers:	K08 AT001315-01A1
Study First Received:	September 9, 2003
Last Updated:	December 9, 2009
Health Authority:	United States: Federal Government

Keywords provided by National Center for Complementary and Integrative Health (NCCIH):


Black cohosh Pharmacokinetics Alternative therapies Natural product

ClinicalTrials.gov processed this record on March 03, 2015

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