Use of Black Cohosh and Red Clover for the Relief of Menopausal Symptoms

October 11, 2007 updated by: National Center for Complementary and Integrative Health (NCCIH)

Black Cohosh and Red Clover Efficacy for the Relief of Menopausal Symptoms

This Phase II study, a follow-up to a Phase I trial in normal volunteers, will determine the efficacy of black cohosh and red clover for the relief of menopausal symptoms. It will also assess the safety of chronic dosing (1 year) by evaluating uterine (endometrial biopsies), breast (mammography), and hematology parameters (CBC and chemistry lab values) at baseline and 1 year.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

112

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Menopausal women with intact uterus
  • Must be experiencing hot flashes
  • No menstrual periods for at least 6 months and no longer than 3 years
  • Non-smoker
  • Must have intact uterus (no hysterectomy)

Exclusion Criteria:

  • Contraindications for hormone replacement therapy
  • Diabetes mellitus
  • Pregnancy or breast-feeding
  • Obese (BMI >35 excluded)
  • History of endometrial hyperplasia/neoplasia/malignancy
  • History of breast or reproductive cancer
  • History of severe recurrent depression, or severe psychiatric disturbance
  • History of stroke/CVA, severe varicose veins, sickle cell anemia, myocardial infarction (heart attack), or arrhythmia (rhythm disturbance of the heart)
  • History of abnormal vaginal bleeding of unknown cause
  • Untreated or uncontrolled high blood pressure/hypertension
  • Use of any medication or supplement containing estrogen, progestin, SERM, St. John's Wort, bisphosphonates, or phytoestrogens
  • History of hormone-associated migraines
  • History of deep vein thrombosis (blood clots), thrombophlebitis, or thromboembolic disorders
  • Participation in a clinical trial within 30 days
  • Abnormal endometrial biopsy or mammogram
  • Abnormal transvaginal ultrasound defined as >7mm thickness
  • Vegan

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Center for Complementary and Integrative Health (NCCIH)

Collaborators

Office of Dietary Supplements (ODS)

Investigators

  • Principal Investigator: Stacie Geller, MD, Department of Obstetrics and Gynecology University of Illinois, Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2003

Study Completion (Actual)

April 1, 2006

Study Registration Dates

First Submitted

August 4, 2003

First Submitted That Met QC Criteria

August 4, 2003

First Posted (Estimate)

August 5, 2003

Study Record Updates

Last Update Posted (Estimate)

October 12, 2007

Last Update Submitted That Met QC Criteria

October 11, 2007

Last Verified

October 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P50AT000155 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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