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

Menopause Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00066144
• Other study ID #: P50AT000155
• Status: Completed
• Phase: Phase 2
• First received: August 4, 2003
• Last updated: October 11, 2007
• Start date: April 2003
• Est. completion date: April 2006

Study information

• Verified date: October 2007
• Source: National Center for Complementary and Integrative Health (NCCIH)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hot Flashes
• Menopause

Intervention

Drug:
• Cimicifuga racemosa

• Trifolium pratense

• Black cohosh

• Red clover

Locations

Country	Name	City	State
United States	University of Illinois at Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
National Center for Complementary and Integrative Health (NCCIH)	Office of Dietary Supplements (ODS)

Country where clinical trial is conducted

United States,