Black Cohosh Extract in Postmenopausal Breast Health

This study has been completed.

First Received on July 14, 2003. Last Updated on December 6, 2007 History of Changes

Sponsor:	National Center for Complementary and Alternative Medicine (NCCAM)
Collaborator:	University of Missouri-Columbia
Information provided by:	National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:	NCT00064831

Purpose

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.

Condition	Intervention	Phase
Menopause Hot Flashes	Drug: Black Cohosh Extract (BCE)	Phase I Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	The Effect of Black Cohosh Extract on the Human Breast

Resource links provided by NLM:

MedlinePlus related topics: Menopause

U.S. FDA Resources

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Estimated Enrollment:	73
Study Start Date:	July 2003
Study Completion Date:	February 2007

Detailed Description:

As in Brief Summary

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00064831

Locations

United States, Missouri
University of Missouri-Columbia
Columbia, Missouri, United States, 65212

Sponsors and Collaborators

National Center for Complementary and Alternative Medicine (NCCAM)

University of Missouri-Columbia

Investigators

Principal Investigator:

Edward Sauter, MD

University of Missouri-Columbia

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Edward Sauter, MD, University of Missouri-Columbia
ClinicalTrials.gov Identifier:	NCT00064831 History of Changes
Other Study ID Numbers:	R21 AT001102-01, SauterE
Study First Received:	July 14, 2003
Last Updated:	December 6, 2007
Health Authority:	United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):

estrogen stimulation
relief of hot flashes
nipple aspirate fluid
body fluid levels of black cohosh

Additional relevant MeSH terms:

Hot Flashes
Signs and Symptoms

ClinicalTrials.gov processed this record on February 13, 2012