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

This study has been completed.

First Received: August 4, 2003 Last Updated: October 11, 2007 History of Changes

Sponsor:	National Center for Complementary and Alternative Medicine (NCCAM)
Collaborator:	Office of Dietary Supplements (ODS)
Information provided by:	National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:	NCT00066144

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Black Cohosh and Red Clover Efficacy for the Relief of Menopausal Symptoms

Resource links provided by NLM:

MedlinePlus related topics: Menopause

Drug Information available for: Cimicifuga

U.S. FDA Resources

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

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

Eligibility

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

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 Alternative Medicine (NCCAM)

Office of Dietary Supplements (ODS)

Investigators

Principal Investigator:

Stacie Geller, MD

Department of Obstetrics and Gynecology University of Illinois, Chicago

More Information

No publications provided by National Center for Complementary and Alternative Medicine (NCCAM)

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Geller SE, Shulman LP, van Breemen RB, Banuvar S, Zhou Y, Epstein G, Hedayat S, Nikolic D, Krause EC, Piersen CE, Bolton JL, Pauli GF, Farnsworth NR. Safety and efficacy of black cohosh and red clover for the management of vasomotor symptoms: a randomized controlled trial. Menopause. 2009 Nov-Dec;16(6):1156-66.

Study ID Numbers:	P50 AT000155
Study First Received:	August 4, 2003
Last Updated:	October 11, 2007
ClinicalTrials.gov Identifier:	NCT00066144 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):

menopause
hot flashes
red clover
black cohosh
sexual dysfunction

Additional relevant MeSH terms:

Signs and Symptoms
Hot Flashes

ClinicalTrials.gov processed this record on November 27, 2009