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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00066144

Enrollment

112

Registered

2003-08-05

Start date

2003-04-30

Completion date

2006-04-30

Last updated

2007-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hot Flashes, Menopause

Keywords

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

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.

Interventions

DRUGCimicifuga racemosa

DRUGTrifolium pratense

DRUGBlack cohosh

DRUGRed clover

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

FEMALE

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026