NCT00064831

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2003

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

July 14, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 15, 2003

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

December 7, 2007

Status Verified

December 1, 2007

First QC Date

July 14, 2003

Last Update Submit

December 6, 2007

Conditions

MenopauseHot Flashes

Keywords

estrogen stimulationrelief of hot flashesnipple aspirate fluidbody fluid levels of black cohosh

Interventions

Black Cohosh Extract (BCE)DRUG

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of Missouri-Columbia

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Conditions

Hot Flashes

Interventions

black cohosh root extract

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Edward Sauter, MD

    University of Missouri-Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
NIH

Study Record Dates

First Submitted

July 14, 2003

First Posted

July 15, 2003

Study Start

July 1, 2003

Study Completion

February 1, 2007

Last Updated

December 7, 2007

Record last verified: 2007-12

Locations

US(1)