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.

Condition	Treatment or Intervention	Phase
Menopause	Drug: Cimicifuga racemosa  Drug: Trifolium pratense	Phase I

Further Study Details: 

Ages Eligible for Study:  45 Years   -   59 Years,  Genders Eligible for Study:  Female

Accepts Healthy Volunteers

Criteria

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

Illinois
      University of Illinois at Chicago, Chicago,  Illinois,  60612,  United States

Study chairs or principal investigators

Suzanne Banuvar, MHSA, CCRC,  Study Director,  University of Illinois   

Study ID Numbers:  1 P50 AT00155-01P4; 1 P50 AT00155-01
Record last reviewed:  October 2004
Last Updated:  October 16, 2004
Record first received:  February 2, 2001
ClinicalTrials.gov Identifier:  NCT00010959
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08