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

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ClinicalTrials.gov Identifier: NCT00066144
Recruitment Status : Completed
First Posted : August 5, 2003
Last Update Posted : October 12, 2007
Sponsor:
Collaborator:
Office of Dietary Supplements (ODS)
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Hot Flashes Menopause Drug: Cimicifuga racemosa Drug: Trifolium pratense Drug: Black cohosh Drug: Red clover Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
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
Study Start Date : April 2003
Actual Study Completion Date : April 2006

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
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
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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
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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
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Principal Investigator: Stacie Geller, MD Department of Obstetrics and Gynecology University of Illinois, Chicago
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00066144    
Other Study ID Numbers: P50AT000155 ( U.S. NIH Grant/Contract )
First Posted: August 5, 2003    Key Record Dates
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:
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Hot Flashes