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A Study of the Pharmacokinetics of Black Cohosh

This study has been terminated.
(PI left institution, study did not continue, funding stopped)
Information provided by:
National Center for Complementary and Integrative Health (NCCIH) Identifier:
First received: September 9, 2003
Last updated: December 9, 2009
Last verified: December 2009
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
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:

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

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT00068185

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)
Principal Investigator: Heather S Shaw, MD Duke University
  More Information

Responsible Party: Heather Shaw, MD, Duke University Identifier: NCT00068185     History of Changes
Other Study ID Numbers: K08AT001315-01A1 ( US NIH Grant/Contract Award Number )
Study First Received: September 9, 2003
Last Updated: December 9, 2009

Keywords provided by National Center for Complementary and Integrative Health (NCCIH):
Black cohosh
Alternative therapies
Natural product

Additional relevant MeSH terms:
Hot Flashes
Signs and Symptoms processed this record on May 25, 2017