A Study of the Pharmacokinetics of Black Cohosh

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

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-08-31

Study Completion Date

2008-07-31

Brief Summary

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Black cohosh is a natural supplement that has been used to treat and prevent menopausal symptoms. Remifemin is a standardized form of black cohosh. The purpose of this study is to determine the levels of components of black cohosh obtained in the blood of healthy women taking Remifemin.

Detailed Description

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As per Brief Summary

Conditions

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Hot Flashes

Keywords

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Black cohosh Pharmacokinetics Alternative therapies Natural product

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Black cohosh

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* No prior diagnosis of cancer other than non-melanoma skin cancer or carcinoma in-situ of the cervix
* No current prescription medication use
* Negative urine pregnancy test OR greater than age 50 with no menses for at least one year OR documented status post hysterectomy
* Competent to understand and sign informed consent

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Duke University

Principal Investigators

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Heather S Shaw, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke University Medical Center

Durham, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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K08AT001315-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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