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NCT00068185 Clinical Trial

A Study of the Pharmacokinetics of Black Cohosh

Hot Flashes Clinical Trial

Official title:
Interactions Between SERMs, Soy and Black Cohosh

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00068185
Other study ID # K08AT001315-01A1
Secondary ID
Status Terminated
Phase Phase 1
First received September 9, 2003
Last updated December 9, 2009
Start date August 2003
Est. completion date July 2008

Study information
Verified date December 2009
Source National Center for Complementary and Integrative Health (NCCIH)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.

Description:

As per Brief Summary

Recruitment information / eligibility
Status Terminated
Enrollment 12
Est. completion date July 2008
Est. primary completion date July 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Black cohosh

Locations
Country Name City State
United States Duke University Medical Center Durham North Carolina

Sponsors (1)
Lead Sponsor Collaborator
National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

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