Herbal Alternatives for Menopause Symptoms (HALT Study)

• Status: Unknown status
• Trial end date: 2004-09-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Group Health Cooperative; Kaiser Permanente
• Collaborators: National Center for Complementary and Integrative Health (NCCIH); National Institute on Aging (NIA)
• Treatments: Estrogens; Estrogens, Conjugated (USP); Medroxyprogesterone; Medroxyprogesterone Acetate

Criteria

Inclusion Criteria:

• female

• age 45 - 55

• peri- or post-menopausal

• moderate to severe vasomotor symptoms

• normal thyroid stimulating hormone

• proof of normal mammogram within past 2 years

Exclusion Criteria:

• use of HT or oral contraceptives within past 3 months

• use of herbs or alternative or complementary medicines for vasomotor symptoms within past 1 month

• medical history of contraindications to HT

• bone mineral density greater than 2 standard deviations below age specific mean

• bilateral oophorectomy

• current use of tamoxifen, raloxifene, bisphosphonates, cholesterol-lowering medications, prescription blood-thinners, or oral steroids

• pregnant or planning to become pregnant

• allergy to soybeans or soy protein

• unable to swallow pills

• current participation in another investigational drug trial

• intention to move out of area in the next 12 months

• non-compliance with procedures involved in screening and run-in trial