NCT00010959

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2001

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2001

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 2, 2001

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 5, 2001

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2002

Completed
Last Updated

March 2, 2007

Status Verified

March 1, 2007

First QC Date

February 2, 2001

Last Update Submit

March 1, 2007

Conditions

Menopause

Keywords

menopausehot flashesbotanicals

Outcome Measures

Primary Outcomes (1)

  • safety

Interventions

Cimicifuga racemosaDRUG
Trifolium pratenseDRUG

Eligibility Criteria

Age45 Years - 59 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy menopausal women
  • Average body weight
  • Able to give informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Hot Flashes

Interventions

black cohosh root extract

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Suzanne Banuvar, MHSA, CCRC

    University of Illinois at Chicago

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH

Study Record Dates

First Submitted

February 2, 2001

First Posted

February 5, 2001

Study Start

February 1, 2001

Study Completion

February 1, 2002

Last Updated

March 2, 2007

Record last verified: 2007-03