Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Text Size

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

This study has been completed.
Sponsor:
Collaborator:
Office of Dietary Supplements (ODS)
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)
ClinicalTrials.gov Identifier:
NCT00066144
First received: August 4, 2003
Last updated: October 11, 2007
Last verified: October 2007
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Black Cohosh and Red Clover Efficacy for the Relief of Menopausal Symptoms

Resource links provided by NLM:

U.S. FDA Resources

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
Ages Eligible for Study:   Child, Adult, Senior
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: August 4, 2003
Last Updated: October 11, 2007
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on September 30, 2016