A Study of the Pharmacokinetics of Black Cohosh
|
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. |
| 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:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
As per Brief Summary
| 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 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
African American Health
Drug Information available for:
Cimicifuga racemosa extract
U.S. FDA Resources
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| 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
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 |
| 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 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:
|
Hot Flashes Signs and Symptoms |