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

Completed · Phase 2

Conditions studied: Hot Flashes, Menopause

In brief

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.

Key facts

Study ID

NCT00066144

Run by

National Center for Complementary and Integrative Health (NCCIH)

People needed

112

Starts

2003-04-01

Expected to finish

2006-04-01

Last updated by the study team

2007-10-12

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• University of Illinois at Chicago — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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