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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
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00010959
Enrollment
30
Registered
2001-02-05
Start date
2001-02-28
Completion date
2002-02-28
Last updated
2007-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Menopause

Keywords

menopause, hot flashes, botanicals

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.

Interventions

DRUGCimicifuga racemosa
DRUGTrifolium pratense

Sponsors

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

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
45 Years to 59 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
safety—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026