A Study of the Pharmacokinetics of Black Cohosh - Tabular View

Tracking Information

First Received Date ^ICMJE

September 9, 2003

Last Updated Date

August 11, 2008

Start Date ^ICMJE

August 2003

Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00068185 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

A Study of the Pharmacokinetics of Black Cohosh

Official Title ^ICMJE

Interactions Between SERMs, Soy and Black Cohosh

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.

Detailed Description

As per Brief Summary

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study

Condition ^ICMJE

Hot Flashes

Intervention ^ICMJE

Drug: Black cohosh

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

July 2008

Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00068185

Responsible Party

Heather Shaw, MD, Duke University

Study ID Numbers ^ICMJE

K08 AT001315-01A1

Study Sponsor ^ICMJE

National Center for Complementary and Alternative Medicine (NCCAM)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Heather S Shaw, MD

Duke University

Information Provided By

National Center for Complementary and Alternative Medicine (NCCAM)

Verification Date

August 2008

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