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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hot Flashes | Drug: Black cohosh | Phase 1 |
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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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
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

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
United States, North Carolina | |
Duke University Medical Center | |
Durham, North Carolina, United States, 27710 |
Principal Investigator: | Heather S Shaw, MD | Duke University |
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 |
Black cohosh Pharmacokinetics Alternative therapies Natural product |
Hot Flashes |