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A Study of the Pharmacokinetics of Black Cohosh

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ClinicalTrials.gov Identifier: NCT00068185
Recruitment Status : Terminated (PI left institution, study did not continue, funding stopped)
First Posted : September 10, 2003
Last Update Posted : December 11, 2009
Sponsor:
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hot Flashes Drug: Black cohosh Phase 1

Detailed Description:
As per Brief Summary
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Interactions Between SERMs, Soy and Black Cohosh
Study Start Date : August 2003
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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
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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
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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
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Principal Investigator: Heather S Shaw, MD Duke University
More Information
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Responsible Party: Heather Shaw, MD, Duke University
ClinicalTrials.gov Identifier: NCT00068185    
Other Study ID Numbers: K08AT001315-01A1 ( U.S. NIH Grant/Contract )
First Posted: September 10, 2003    Key Record Dates
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:
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Hot Flashes