Black Cohosh Extract in Postmenopausal Breast Health - Tabular View

Tracking Information

First Received Date ^ICMJE

July 14, 2003

Last Updated Date

December 6, 2007

Start Date ^ICMJE

July 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00064831 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Black Cohosh Extract in Postmenopausal Breast Health

Official Title ^ICMJE

The Effect of Black Cohosh Extract on the Human Breast

Brief Summary

The purpose of the study is to determine if black cohosh extract (BCE) administration in symptomatic postmenopausal women results in estrogenic stimulation of the breast, as determined by estradiol, pS2, FSH, LH, and PSA levels in nipple aspirate fluid.

Detailed Description

As in Brief Summary

Study Phase

Phase I, Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Menopause
Hot Flashes

Intervention ^ICMJE

Drug: Black Cohosh Extract (BCE)

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

Enrollment ^ICMJE

Completion Date

February 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

Postmenopausal females
20 months since any breastfeeding
Active postmenopausal symptoms, i.e., hot flashes
At least 6 months since last menstrual period or have had a hysterectomy with both ovaries removed
Able to make 4 visits during the trial to the study clinic in Columbia, Missouri

Gender

Female

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00064831

Responsible Party

Edward Sauter, MD, University of Missouri-Columbia

Study ID Numbers ^ICMJE

R21 AT001102-01, SauterE

Study Sponsor ^ICMJE

National Center for Complementary and Alternative Medicine (NCCAM)

Collaborators ^ICMJE

University of Missouri-Columbia

Investigators ^ICMJE

Principal Investigator:

Edward Sauter, MD

University of Missouri-Columbia

Information Provided By

National Center for Complementary and Alternative Medicine (NCCAM)

Verification Date

December 2007

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