Vasomotor Symptoms Associated With Menopause Clinical Trial
Official title:
Herbal Alternatives for Menopause Symptoms: A Randomized Trial
Verified date | September 2005 |
Source | Group Health Cooperative |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 351 |
Est. completion date | September 2004 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 45 Years to 55 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Group Health Cooperative, Center for Health Studies | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
Group Health Cooperative | National Center for Complementary and Integrative Health (NCCIH), National Institute on Aging (NIA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Self report daily diary of frequency and intensity of vasomotor symptoms at BL, 3, 6 and 12 months. | |||
Primary | Wiklund Menopause Symptom Checklist at BL, 3, 6 and 12 months. | |||
Secondary | Vaginal cytology (vaginal maturation index)at BL, 3 and 12 months. | |||
Secondary | Serum lipids (total cholesterol, HDL and LDL cholesterol, triglycerides) at BL, 3, 6, and 12 months. | |||
Secondary | Bone mineral density (hip and spine dual energy x-ray absorptiometry scan) at BL, 6 and 12 months. | |||
Secondary | Glucose metabolism (insulin, fasting blood glucose) at BL, 3, 6, and 12 months. | |||
Secondary | Coagulation factors (fibrinogen, PAI-1) at BL, 3, 6, and 12 months. |
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