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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00066144
First Posted: August 5, 2003
Last Update Posted: October 12, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Office of Dietary Supplements (ODS)
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)
  Purpose
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.

Condition Intervention Phase
Hot Flashes Menopause Drug: Cimicifuga racemosa Drug: Trifolium pratense Drug: Black cohosh Drug: Red clover Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Black Cohosh and Red Clover Efficacy for the Relief of Menopausal Symptoms

Resource links provided by NLM:


Further study details as provided by National Center for Complementary and Integrative Health (NCCIH):

Estimated Enrollment: 112
Study Start Date: April 2003
Study Completion Date: April 2006
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00066144


Locations
United States, Illinois
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Office of Dietary Supplements (ODS)
Investigators
Principal Investigator: Stacie Geller, MD Department of Obstetrics and Gynecology University of Illinois, Chicago
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00066144     History of Changes
Other Study ID Numbers: P50AT000155 ( U.S. NIH Grant/Contract )
First Submitted: August 4, 2003
First Posted: August 5, 2003
Last Update Posted: October 12, 2007
Last Verified: October 2007

Keywords provided by National Center for Complementary and Integrative Health (NCCIH):
menopause
hot flashes
red clover
black cohosh
sexual dysfunction

Additional relevant MeSH terms:
Hot Flashes
Signs and Symptoms