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Black Cohosh Extract in Postmenopausal Breast Health

This study has been completed.
Sponsor:
Collaborator:
University of Missouri-Columbia
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00064831
First received: July 14, 2003
Last updated: December 6, 2007
Last verified: December 2007
History of Changes
  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 1
Phase 2

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

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 May 16, 2013