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

Primary Purpose

Hot Flashes, Menopause

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cimicifuga racemosa
Trifolium pratense
Black cohosh
Red clover
Sponsored by
National Center for Complementary and Integrative Health (NCCIH)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hot Flashes focused on measuring menopause, hot flashes, red clover, black cohosh, sexual dysfunction

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • University of Illinois at Chicago

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 4, 2003
Last Updated
October 11, 2007
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborators
Office of Dietary Supplements (ODS)
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1. Study Identification

Unique Protocol Identification Number
NCT00066144
Brief Title
Use of Black Cohosh and Red Clover for the Relief of Menopausal Symptoms
Official Title
Black Cohosh and Red Clover Efficacy for the Relief of Menopausal Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborators
Office of Dietary Supplements (ODS)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hot Flashes, Menopause
Keywords
menopause, hot flashes, red clover, black cohosh, sexual dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
112 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Cimicifuga racemosa
Intervention Type
Drug
Intervention Name(s)
Trifolium pratense
Intervention Type
Drug
Intervention Name(s)
Black cohosh
Intervention Type
Drug
Intervention Name(s)
Red clover

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stacie Geller, MD
Organizational Affiliation
Department of Obstetrics and Gynecology University of Illinois, Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19609225
Citation
Geller SE, Shulman LP, van Breemen RB, Banuvar S, Zhou Y, Epstein G, Hedayat S, Nikolic D, Krause EC, Piersen CE, Bolton JL, Pauli GF, Farnsworth NR. Safety and efficacy of black cohosh and red clover for the management of vasomotor symptoms: a randomized controlled trial. Menopause. 2009 Nov-Dec;16(6):1156-66. doi: 10.1097/gme.0b013e3181ace49b.
Results Reference
derived

Learn more about this trial

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

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