Expired Study
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Chicago, Illinois 60612


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.


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


Study is Available At:


Original ID:

P50 AT000155


NCT ID:

NCT00066144


Secondary ID:


Study Acronym:


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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Female


Minimum Age:

N/A


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Center for Complementary and Alternative Medicine (NCCAM)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

112


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Stacie Geller, MD
Principal Investigator
Department of Obstetrics and Gynecology University of Illinois, Chicago

Study Dates

Start Date:April 2003
Completion Date:April 2006
Completion Type:Actual
Verification Date:October 2007
Last Changed Date:October 11, 2007
First Received Date:August 4, 2003

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:Cimicifuga racemosa
Intervention Type:Drug
Name:Trifolium pratense
Intervention Type:Drug
Name:Black cohosh
Intervention Type:Drug
Name:Red clover

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Center for Complementary and Alternative Medicine (NCCAM)
Agency Class:NIH
Agency Type:Collaborator
Agency Name:Office of Dietary Supplements (ODS)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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