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Black Cohosh Extract in Postmenopausal Breast Health

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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)

Tracking Information
First Submitted Date  ICMJE July 14, 2003
First Posted Date  ICMJE July 15, 2003
Last Update Posted Date December 7, 2007
Study Start Date  ICMJE July 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00064831 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Black Cohosh Extract in Postmenopausal Breast Health
Official Title  ICMJE The Effect of Black Cohosh Extract on the Human Breast
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.
Detailed Description As in Brief Summary
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Menopause
  • Hot Flashes
Intervention  ICMJE Drug: Black Cohosh Extract (BCE)
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June¬†23,¬†2005)
73
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00064831
Other Study ID Numbers  ICMJE R21AT001102-01( U.S. NIH Grant/Contract )
SauterE
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Edward Sauter, MD, University of Missouri-Columbia
Study Sponsor  ICMJE National Center for Complementary and Integrative Health (NCCIH)
Collaborators  ICMJE University of Missouri-Columbia
Investigators  ICMJE
Principal Investigator: Edward Sauter, MD University of Missouri-Columbia
PRS Account National Center for Complementary and Integrative Health (NCCIH)
Verification Date December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP