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

National Institutes of Health (NIH)

Status and phase

Completed

Phase 2

Conditions

Menopause

Hot Flashes

Treatments

Drug: Black cohosh

Drug: Trifolium pratense

Drug: Red clover

Drug: Cimicifuga racemosa

Study type

Interventional

Funder types

NIH

Identifiers

NCT00066144

P50AT000155

Details and patient eligibility

About

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.

Enrollment

112 estimated patients

Sex

Female

Volunteers

No Healthy Volunteers

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