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Black Cohosh Extract in Postmenopausal Breast Health

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ClinicalTrials.gov Identifier: NCT00064831
Recruitment Status : Completed
First Posted : July 15, 2003
Last Update Posted : December 7, 2007
Sponsor:
Collaborator:
University of Missouri-Columbia
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)

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.

Condition or disease Intervention/treatment Phase
Menopause Hot Flashes Drug: Black Cohosh Extract (BCE) Phase 1 Phase 2

Detailed Description:
As in Brief Summary

Study Type : Interventional  (Clinical Trial)
Enrollment : 73 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Effect of Black Cohosh Extract on the Human Breast
Study Start Date : July 2003
Actual Study Completion Date : February 2007

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U.S. FDA Resources





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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00064831


Locations
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
Investigators
Principal Investigator: Edward Sauter, MD University of Missouri-Columbia

Responsible Party: Edward Sauter, MD, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT00064831     History of Changes
Other Study ID Numbers: R21AT001102-01 ( U.S. NIH Grant/Contract )
SauterE
First Posted: July 15, 2003    Key Record Dates
Last Update Posted: December 7, 2007
Last Verified: December 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