Status:
UNKNOWN
Herbal Alternatives for Menopause Symptoms (HALT Study)
Lead Sponsor:
Kaiser Permanente
Collaborating Sponsors:
National Institute on Aging (NIA)
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Vasomotor Symptoms Associated With Menopause
Eligibility:
FEMALE
45-55 years
Phase:
PHASE4
Brief 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 thes...
Detailed Description
Hormone replacement therapy (HT: estrogen and progestin) remains the treatment of choice for women with vasomotor symptoms, and long-term HT has been recommended for prevention purposes. The demand fo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2001
Trial Type :
INTERVENTIONAL
End Date :
September 1 2004
Estimated Enrollment :
351 Patients enrolled
Trial Details
Trial ID
NCT00169299
Start Date
June 1 2001
End Date
September 1 2004
Last Update
September 15 2005
Active Locations (1)
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1
Group Health Cooperative, Center for Health Studies
Seattle, Washington, United States, 98101-1448