drugset / Trial / NCT00169299

Herbal Alternatives for Menopause Symptoms (HALT Study)

NCT00169299 ↗

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2001-06
Primary completion
—
Completion
2004-09

Outcome

Missed primary endpoint

paper Vasomotor symptoms per day, symptom intensity, Wiklund Vasomotor Symptom Subscale score did not differ between the herbal interventions and placebo PMID 17179056 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Black Cohosh Traditional medicine (herbal / TCM) 160 mg —
Subject Multibotanical preparation Unknown 200 mg —
Subject conjugated equine estrogen Unknown 0.625 mg —
Subject medroxyprogesterone acetate Other / unclassified 2.5 mg —

Indications

No indication recorded.