MedDataX Logo

Black Cohosh Extract in Postmenopausal Breast Health

NCT ID: NCT00064831

Last Updated: 2007-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-07-31

Study Completion Date

2007-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

As in Brief Summary

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Menopause Hot Flashes

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

estrogen stimulation relief of hot flashes nipple aspirate fluid body fluid levels of black cohosh

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Black Cohosh Extract (BCE)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion 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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Missouri-Columbia

OTHER

Sponsor Role collaborator

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

University of Missouri-Columbia

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Edward Sauter, MD

Role: PRINCIPAL_INVESTIGATOR

University of Missouri-Columbia

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Missouri-Columbia

Columbia, Missouri, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SauterE

Identifier Type: -

Identifier Source: secondary_id

R21AT001102-01

Identifier Type: NIH

Identifier Source: org_study_id

View Link