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Completed

NCT Number: NCT00066144

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

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.

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Key information

Conditions

Hot Flashes Genital Diseases Menopause Pathological Conditions, Signs and Symptoms Sexual Dysfunction, Physiological Signs and Symptoms Urogenital Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cimicifuga racemosa

Drug

Trifolium pratense

Drug

Black Cohosh

Drug

Red clover

Drug

Sponsors and collaborators

Lead sponsor

National Center for Complementary and Integrative Health (NCCIH)

Nih

Collaborators

  • Office of Dietary Supplements (ODS)

Registry information

Official study title

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

Important dates

Study start
2003
Study completion
2006
First posted
Aug 5, 2003
Registry last updated
Oct 12, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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