NCT00010959

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (planned)
• Sponsor: National Center for Complementary and Integrative Health (NCCIH) · NIH
• Sex: Female
• Age: 45 Years – 59 Years
• Healthy volunteers: Accepted

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.

Conditions

• Menopause

Interventions

Type	Name	Description
DRUG	Cimicifuga racemosa
DRUG	Trifolium pratense

Timeline

• Start date: 2001-02-01
• Completion: 2002-02-01
• First posted: 2001-02-05
• Last updated: 2007-03-02