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 Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00068185
First received: September 9, 2003
Last updated: December 9, 2009
Last verified: December 2009

September 9, 2003
December 9, 2009
August 2003
July 2008   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00068185 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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A Study of the Pharmacokinetics of Black Cohosh
Interactions Between SERMs, Soy and Black Cohosh

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.

As per Brief Summary

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hot Flashes
Drug: Black cohosh
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
12
July 2008
July 2008   (final data collection date for primary outcome measure)

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
Female
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00068185
K08 AT001315-01A1
Yes
Heather Shaw, MD, Duke University
National Center for Complementary and Alternative Medicine (NCCAM)
Not Provided
Principal Investigator: Heather S Shaw, MD Duke University
National Center for Complementary and Alternative Medicine (NCCAM)
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP