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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 17 October 2012
Main ID:  NCT00068185
Date of registration: 09/09/2003
Primary sponsor: National Center for Complementary and Alternative Medicine (NCCAM)
Public title: A Study of the Pharmacokinetics of Black Cohosh
Scientific title: Interactions Between SERMs, Soy and Black Cohosh
Date of first enrolment: August 2003
Target sample size: 12
Recruitment status: Terminated
URL:  http://clinicaltrials.gov/show/NCT00068185
Study type:  Interventional
Study design:  Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment  
Countries of recruitment
United States
Contacts
Name:   Heather S Shaw, MD
Address: 
Telephone:
Email:
Affiliation:  Duke University
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Female
Health Condition(s) or Problem(s) studied
Hot Flashes
Intervention(s)
Drug: Black cohosh
Primary Outcome(s)
Secondary Outcome(s)
Secondary ID(s)
K08 AT001315-01A1
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
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