Single-Dose Study of Black Cohosh and Red Clover - Tabular View

Tracking Information

First Received Date ^ICMJE

February 2, 2001

Last Updated Date

March 1, 2007

Start Date ^ICMJE

February 2001

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

safety

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00010959 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Single-Dose Study of Black Cohosh and Red Clover

Official Title ^ICMJE

A Phase I Single-Dose Pharmacokinetic Study of Black Cohosh and Red Clover in Healthy Menopausal Women 45-59 Years of Age

Brief Summary

Detailed Description

This Phase I study will assess the pharmacokinetics of two botanicals, Trifolium pratense (red clover) and Cimicifuga racemosa (black cohosh). Participants will receive a single dose of one botanical preparation. The observation period will be one week. Drug toxicity, absorption, distribution, metabolism and elimination data will be collected, and dosages to be utilized in a Phase II clinical trial will be determined. The Phase II trial will examine the efficacies of red clover and black cohosh for the reduction of menopausal symptoms in healthy menopausal women. The study will be randomized, double-blinded, and placebo-controlled. Study duration will be one year.

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Condition ^ICMJE

Menopause

Intervention ^ICMJE

Drug: Cimicifuga racemosa
Drug: Trifolium pratense

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2002

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Healthy menopausal women
Average body weight
Able to give informed consent

Exclusion Criteria:

Smoker
Use of any prescription medicine within the last 2 months
Obesity > 30% above ideal body weight
Previous history of breast or reproductive cancer
Alcohol abuse or consumption above 5 glasses of wine per week or equivalent
Chronic disease such as diabetes or hypertension
Concurrent non-dietary phytoestrogens or hormone use; Vegans (vegetarians who tend to consume greater than average dose of phytoestrogens)
Concurrent participation in other clinical trial(s)
Unavailable for followup

Gender

Female

Ages

45 Years to 59 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00010959

Responsible Party

Study ID Numbers ^ICMJE

P50 AT000155-01P4, P50 AT000155-01

Study Sponsor ^ICMJE

National Center for Complementary and Alternative Medicine (NCCAM)

Collaborators ^ICMJE

National Institute of General Medical Sciences (NIGMS)
Office of Dietary Supplements (ODS)

Investigators ^ICMJE

Study Director:

Suzanne Banuvar, MHSA, CCRC

University of Illinois

Information Provided By

National Center for Complementary and Alternative Medicine (NCCAM)

Verification Date

March 2007

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