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

NCT00066144 | Completed Phase 2 DMC

• 1 other identifier: P50AT000155
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Hot Flashes; Menopause

Keywords

menopause; hot flashes; red clover; black cohosh; sexual dysfunction

Interventions

Cimicifuga racemosa DRUG

Trifolium pratense DRUG

Black cohosh DRUG

Red clover DRUG

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• National Center for Complementary and Integrative Health (NCCIH): lead
• Office of Dietary Supplements (ODS): collaborator

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Related Publications (1)

• 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.

  PMID: 19609225 DERIVED

MeSH Terms

Conditions

Hot Flashes; Sexual Dysfunction, Physiological

Interventions

black cohosh root extract

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Genital Diseases; Urogenital Diseases

Study Officials

• Stacie Geller, MD

  Department of Obstetrics and Gynecology University of Illinois, Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: August 4, 2003
• First Posted: August 5, 2003
• Study Start: April 1, 2003
• Study Completion: April 1, 2006
• Last Updated: October 12, 2007

Record last verified: 2007-10

Locations

US (1)