Black Cohosh Extract in Postmenopausal Breast Health

December 6, 2007 updated by: National Center for Complementary and Integrative Health (NCCIH)

The Effect of Black Cohosh Extract on the Human Breast

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

As in Brief Summary

Study Type

Interventional

Enrollment

73

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Center for Complementary and Integrative Health (NCCIH)

Collaborators

University of Missouri-Columbia

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Study Completion (Actual)

February 1, 2007

Study Registration Dates

First Submitted

July 14, 2003

First Submitted That Met QC Criteria

July 14, 2003

First Posted (Estimate)

July 15, 2003

Study Record Updates

Last Update Posted (Estimate)

December 7, 2007

Last Update Submitted That Met QC Criteria

December 6, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R21AT001102-01 (U.S. NIH Grant/Contract)
  • SauterE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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