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Herbal Alternatives for Menopause Symptoms (HALT Study)

NCT00169299 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 351

Last updated 2005-09-15

No results posted yet for this study

Summary

Surveys indicate that 25 to 33% of women have moderate to severe menopausal symptoms including hot flashes, night sweats, and disturbed sleep. The treatment of choice in the medical community for these symptoms is hormone replacement therapy, which is estrogen and sometimes progestin. Many women also use over-the-counter herbal remedies. However, less is known about how well these products work, or their safety. Few have undergone the kind of rigorous testing required of prescription drugs and little is known about their long-term effectiveness in relieving symptoms.

The purpose of this study is to compare several over-the-counter herbal remedies to hormone replacement therapy. Our primary aim is to look at the effects of these remedies on your self-reported menopausal symptoms. We will also be measuring their effects on other factors known to be affected by hormone replacement therapy: cholesterol, blood sugar, bone density, vaginal cell structure, and blood clotting.

Conditions

  • Vasomotor Symptoms Associated With Menopause

Interventions

DRUG

Black cohosh

DRUG

Multibotanical preparation

DRUG

Multibotanical preparation + dietary soy counseling

DRUG

Conjugated equine estrogen +/- medroxyprogesterone acetate

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH

  • National Center for Complementary and Integrative Health (NCCIH)

    collaborator NIH

  • Kaiser Permanente

    lead OTHER

Principal Investigators

  • Katherine M Newton, PhD · Group Health Cooperative, Center for Health Studies

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2001-06-30
Completion
2004-09-30

Countries

  • United States

Study Locations

More Related Trials

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 NCT00169299 on ClinicalTrials.gov