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:

MedlinePlus related topics: African American Health Menopause

Drug Information available for: Cimicifuga racemosa extract Red clover

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

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):

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. doi: 10.1097/gme.0b013e3181ace49b.


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

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