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

Tracking Information

First Received Date ^ICMJE

August 4, 2003

Last Updated Date

October 11, 2007

Start Date ^ICMJE

April 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00066144 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Hot Flashes
Menopause

Intervention ^ICMJE

Drug: Cimicifuga racemosa
Drug: Trifolium pratense
Drug: Black cohosh
Drug: Red clover

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

112

Completion Date

April 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00066144

Responsible Party

Study ID Numbers ^ICMJE

P50 AT000155

Study Sponsor ^ICMJE

National Center for Complementary and Alternative Medicine (NCCAM)

Collaborators ^ICMJE

Office of Dietary Supplements (ODS)

Investigators ^ICMJE

Principal Investigator:

Stacie Geller, MD

Department of Obstetrics and Gynecology University of Illinois, Chicago

Information Provided By

National Center for Complementary and Alternative Medicine (NCCAM)

Verification Date

October 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP