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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)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00068185
First Posted: September 10, 2003
Last Update Posted: December 11, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)
  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
Intervention Model: Single Group Assignment
Masking: None (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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Heather Shaw, MD, Duke University
ClinicalTrials.gov Identifier: NCT00068185     History of Changes
Other Study ID Numbers: K08AT001315-01A1 ( U.S. NIH Grant/Contract )
First Submitted: September 9, 2003
First Posted: September 10, 2003
Last Update Posted: December 11, 2009
Last Verified: December 2009

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

Additional relevant MeSH terms:
Hot Flashes
Signs and Symptoms