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Use of Black Cohosh and Red Clover for the Relief of Menopausal Symptoms
This study has been completed.
Sponsor:
National Center for Complementary and Integrative Health (NCCIH)
Collaborator:
Office of Dietary Supplements (ODS)
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)
ClinicalTrials.gov Identifier:
NCT00066144
First received: August 4, 2003
Last updated: October 11, 2007
Last verified: October 2007
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Hot Flashes Menopause | Drug: Cimicifuga racemosa Drug: Trifolium pratense Drug: Black cohosh Drug: Red clover | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Black Cohosh and Red Clover Efficacy for the Relief of Menopausal Symptoms |
Resource links provided by NLM:
Further study details as provided by National Center for Complementary and Integrative Health (NCCIH):
Eligibility| Ages Eligible for Study: | Child, Adult, Senior |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00066144
Please refer to this study by its ClinicalTrials.gov identifier: NCT00066144
Locations
| United States, Illinois | |
| University of Illinois at Chicago | |
| Chicago, Illinois, United States, 60612 | |
Sponsors and Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Office of Dietary Supplements (ODS)
Investigators
| Principal Investigator: | Stacie Geller, MD | Department of Obstetrics and Gynecology University of Illinois, Chicago |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00066144 History of Changes |
| Other Study ID Numbers: |
P50AT000155 ( US NIH Grant/Contract Award Number ) |
| Study First Received: | August 4, 2003 |
| Last Updated: | October 11, 2007 |
Keywords provided by National Center for Complementary and Integrative Health (NCCIH):
|
menopause hot flashes red clover black cohosh sexual dysfunction |
Additional relevant MeSH terms:
|
Hot Flashes Signs and Symptoms |
ClinicalTrials.gov processed this record on June 28, 2017