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

Phase 2

Completed

• Conditions: Hot Flashes; Menopause

• Registration Number: NCT00066144
• Lead Sponsor: National Center for Complementary and Integrative Health (NCCIH)

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

Not available

Study Timeline

• Study Start: 2003-04
• Study First Submitted: 2003-08-04
• Study First Submitted QC: 2003-08-04
• Study First Posted: 2003-08-05
• Study Completion: 2006-04
• Status Verified: 2007-10
• Last Update Submitted: 2007-10-11
• Last Update Posted: 2007-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 112

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (1)

University of Illinois at Chicago; 🇺🇸 Chicago, Illinois, United States