Single-Dose Study of Black Cohosh and Red Clover

Phase 1

Completed

• Conditions: Menopause

• Registration Number: NCT00010959
• Lead Sponsor: National Center for Complementary and Integrative Health (NCCIH)

Brief Summary

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.

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 Timeline

• Study Start: 2001-02
• Study First Submitted: 2001-02-02
• Study First Submitted QC: 2001-02-02
• Study First Posted: 2001-02-05
• Study Completion: 2002-02
• Status Verified: 2007-03
• Last Update Submitted: 2007-03-01
• Last Update Posted: 2007-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
safety