Single-Dose Study of Black Cohosh and Red Clover

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

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.

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.

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