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Single-Dose Study of Black Cohosh and Red Clover



Single-Dose Study of Black Cohosh and Red Clover

For Condition: Menopause
Status: No longer recruiting
Sponsor(s): National Center for Complementary and Alternative Medicine (NCCAM) , National Institute of General Medical Sciences (NIGMS),Office of Dietary Supplements (ODS),Office of Research on Women's Health (ORWH)
Synopsis: 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.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Open Label
Minimum Age/Maximum Age: 45 Years/59 Years
Genders: Female
Protocol Entry Criteria: 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
SuzanneBanuvar,  Study Director,  University of Illinois

University of Illinois at Chicago
Chicago,  Illinois,  60612
United States
 


Additional Information:
Study ID Numbers:
  1 P50 AT00155-01P4;  1 P50 AT00155-01
Study Start Date: February 2001
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00010959

Other Menopause Studies:
1. Single-Dose Study of Black Cohosh and Red Clover

2. Black Cohosh Extract in Postmenopausal Breast Health

3. Development and Evaluation of a Hormone Replacement Therapy Decision-Aid

4. Soy Estrogen Alternative Study (SEA)

5. Nurses' Health Study

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