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NCT00064831 Clinical Trial

Black Cohosh Extract in Postmenopausal Breast Health

Menopause Clinical Trial

Official title:
The Effect of Black Cohosh Extract on the Human Breast

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00064831
Other study ID # R21AT001102-01
Secondary ID SauterE
Status Completed
Phase Phase 1/Phase 2
First received July 14, 2003
Last updated December 6, 2007
Start date July 2003
Est. completion date February 2007

Study information
Verified date December 2007
Source National Center for Complementary and Integrative Health (NCCIH)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.

Description:

As in Brief Summary

Recruitment information / eligibility
Status Completed
Enrollment 73
Est. completion date February 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility - 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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Black Cohosh Extract (BCE)

Locations
Country Name City State
United States University of Missouri-Columbia Columbia Missouri

Sponsors (2)
Lead Sponsor Collaborator
National Center for Complementary and Integrative Health (NCCIH) University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

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