Expired Study
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Columbia, Missouri 65212


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.


Study summary:

As in Brief Summary


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


Study is Available At:


Original ID:

R21 AT001102-01


NCT ID:

NCT00064831


Secondary ID:

SauterE


Study Acronym:


Brief Title:

Black Cohosh Extract in Postmenopausal Breast Health


Official Title:

The Effect of Black Cohosh Extract on the Human Breast


Overall Status:

Completed


Study Phase:

Phase 1/Phase 2


Genders:

Female


Minimum Age:

N/A


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Center for Complementary and Alternative Medicine (NCCAM)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificati


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

73


Enrollment Type:


Overall Contact Information

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

Study Dates

Start Date:July 2003
Completion Date:February 2007
Completion Type:Actual
Verification Date:December 2007
Last Changed Date:December 6, 2007
First Received Date:July 14, 2003

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:Black Cohosh Extract (BCE)

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Center for Complementary and Alternative Medicine (NCCAM)
Agency Class:Other
Agency Type:Collaborator
Agency Name:University of Missouri-Columbia

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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