Single-Dose Study of Black Cohosh and Red Clover

Menopause Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00010959
• Other study ID #: P50 AT000155-01P4
• Secondary ID: P50AT000155-01
• Status: Completed
• Phase: Phase 1
• First received: February 2, 2001
• Last updated: March 1, 2007
• Start date: February 2001
• Est. completion date: February 2002

Study information

• Verified date: March 2007
• Source: National Center for Complementary and Integrative Health (NCCIH)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00008970

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 2002
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 59 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Menopause

Intervention

Drug:
• Cimicifuga racemosa

• Trifolium pratense

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
National Center for Complementary and Integrative Health (NCCIH)	National Institute of General Medical Sciences (NIGMS), Office of Dietary Supplements (ODS)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	safety

External Links

•   Click here for information on the UIC/NIH Center for Botanical Dietary Supplements Research