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CompletedNCT00066144Updated Oct 12, 2007

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

A Phase 2 interventional study of Cimicifuga racemosa and Trifolium pratense in Hot Flashes and Menopause, sponsored by National Center for Complementary and Integrative Health (NCCIH). Completed at 1 site in United States. Open to female participants. Per ClinicalTrials.gov, last updated 2007-10-12.

Sponsored by National Center for Complementary and Integrative Health (NCCIH) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
112
Allocation
Randomized
Sex
Female
01

Study 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.

02

Conditions studied

  • Hot Flashes
  • Menopause

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Keywords

  • menopause
  • hot flashes
  • red clover
  • black cohosh
  • sexual dysfunction
03

In context

Hot Flashes

285 studies on the registry are indexed under Hot Flashes; 50 are open to participants now.

This study's planned enrollment of 112 is above the median of 90 across 255 interventional studies indexed under Hot Flashes.

Browse Hot Flashes studies →

Lead sponsor

National Center for Complementary and Integrative Health (NCCIH) is the lead sponsor of 218 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
112 participants (estimated)

Interventions

  • DrugCimicifuga racemosa
  • DrugTrifolium pratense
  • DrugBlack cohosh
  • DrugRed clover
06

Study locations

1 site
  • University of Illinois at Chicago
    Chicago, Illinois 60612, United States
07

References and documents

Publications

  • 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. PubMed 19609225 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 12, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00066144
Lead sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborators
Office of Dietary Supplements (ODS)
First posted
Aug 5, 2003
Start date
Apr 2003
Completion
Apr 2006
Last update
Oct 12, 2007

Study contacts

Stacie Geller, MD
principal investigator · Department of Obstetrics and Gynecology University of Illinois, Chicago

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2007. You cannot join it, but the record below documents what was studied.

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