Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Black Cohosh Extract in Postmenopausal Breast Health

This study has been completed.
University of Missouri-Columbia
Information provided by:
National Center for Complementary and Integrative Health (NCCIH) Identifier:
First received: July 14, 2003
Last updated: December 6, 2007
Last verified: December 2007
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
Hot Flashes
Drug: Black Cohosh Extract (BCE)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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:

Further study details as provided by National Center for Complementary and Integrative Health (NCCIH):

Estimated Enrollment: 73
Study Start Date: July 2003
Study Completion Date: February 2007
Detailed Description:
As in Brief Summary

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00064831

United States, Missouri
University of Missouri-Columbia
Columbia, Missouri, United States, 65212
Sponsors and Collaborators
National Center for Complementary and Integrative Health (NCCIH)
University of Missouri-Columbia
Principal Investigator: Edward Sauter, MD University of Missouri-Columbia
  More Information

Responsible Party: Edward Sauter, MD, University of Missouri-Columbia Identifier: NCT00064831     History of Changes
Other Study ID Numbers: R21AT001102-01 ( US NIH Grant/Contract Award Number )
Study First Received: July 14, 2003
Last Updated: December 6, 2007

Keywords provided by National Center for Complementary and Integrative Health (NCCIH):
estrogen stimulation
relief of hot flashes
nipple aspirate fluid
body fluid levels of black cohosh

Additional relevant MeSH terms:
Hot Flashes
Signs and Symptoms processed this record on May 23, 2017