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

NCT00066144 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2007-10-12

No results posted yet for this 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.

Conditions

Interventions

DRUG

Cimicifuga racemosa

DRUG

Trifolium pratense

DRUG

Black cohosh

DRUG

Red clover

Sponsors & Collaborators

  • Office of Dietary Supplements (ODS)

    collaborator NIH

  • National Center for Complementary and Integrative Health (NCCIH)

    lead NIH

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-04-30
Completion
2006-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00066144 on ClinicalTrials.gov