Use of Black Cohosh and Red Clover for the Relief of Menopausal Symptoms
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00066144 |
Recruitment Status :
Completed
First Posted : August 5, 2003
Last Update Posted : October 12, 2007
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hot Flashes Menopause | Drug: Cimicifuga racemosa Drug: Trifolium pratense Drug: Black cohosh Drug: Red clover | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 112 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | Black Cohosh and Red Clover Efficacy for the Relief of Menopausal Symptoms |
Study Start Date : | April 2003 |
Actual Study Completion Date : | April 2006 |


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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00066144
United States, Illinois | |
University of Illinois at Chicago | |
Chicago, Illinois, United States, 60612 |
Principal Investigator: | Stacie Geller, MD | Department of Obstetrics and Gynecology University of Illinois, Chicago |
ClinicalTrials.gov Identifier: | NCT00066144 |
Other Study ID Numbers: |
P50AT000155 ( U.S. NIH Grant/Contract ) |
First Posted: | August 5, 2003 Key Record Dates |
Last Update Posted: | October 12, 2007 |
Last Verified: | October 2007 |
menopause hot flashes red clover black cohosh sexual dysfunction |
Hot Flashes |