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Herbal Alternatives for Menopause Symptoms (HALT Study)

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ClinicalTrials.gov Identifier: NCT00169299
Recruitment Status : Unknown
Verified September 2005 by Kaiser Permanente.
Recruitment status was:  Active, not recruiting
First Posted : September 15, 2005
Last Update Posted : September 15, 2005
Sponsor:
Collaborators:
National Institute on Aging (NIA)
National Center for Complementary and Integrative Health (NCCIH)
Information provided by:
Kaiser Permanente

Tracking Information
First Submitted Date  ICMJE September 12, 2005
First Posted Date  ICMJE September 15, 2005
Last Update Posted Date September 15, 2005
Study Start Date  ICMJE June 2001
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
  • Self report daily diary of frequency and intensity of vasomotor symptoms at BL, 3, 6 and 12 months.
  • Wiklund Menopause Symptom Checklist at BL, 3, 6 and 12 months.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
  • Vaginal cytology (vaginal maturation index)at BL, 3 and 12 months.
  • Serum lipids (total cholesterol, HDL and LDL cholesterol, triglycerides) at BL, 3, 6, and 12 months.
  • Bone mineral density (hip and spine dual energy x-ray absorptiometry scan) at BL, 6 and 12 months.
  • Glucose metabolism (insulin, fasting blood glucose) at BL, 3, 6, and 12 months.
  • Coagulation factors (fibrinogen, PAI-1) at BL, 3, 6, and 12 months.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Herbal Alternatives for Menopause Symptoms (HALT Study)
Official Title  ICMJE Herbal Alternatives for Menopause Symptoms: A Randomized Trial
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 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.

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 for alternatives to HT, and the availability and use of over-the-counter products including dietary phytoestrogen supplements, and naturopathic medicines has grown dramatically. Few of these products have faced the rigors of randomized trials and none have been tested to evaluate their effects on long-term outcomes.

The purpose of this 4-year, randomized controlled trial is to evaluate the efficacy and safety of three alternative approaches utilizing phytoestrogens to treat vasomotor symptoms in peri- and postmenopausal women. The treatments were chosen because of the scientific evidence supporting a possible benefit, the availability of products with adequate quality control, their frequency of use in naturopathic medicine, and our ability to blind participants to the intervention. The 5 proposed treatment arms are: 1) conjugated equine estrogen with or without medroxyprogesterone acetate in women with or without an intact uterus respectively; 2) a single herbal product, black cohosh; 3) a multibotanical preparation; 4) a combination regimen that includes the same multibotanical preparation plus soy diet counseling; and 5) placebo. Our primary aim is to compare the effects of three alternative treatments, HRT and placebo on the frequency and intensity of vasomotor symptoms measured by The Wiklund Menopause Symptom Checklist and a daily Vasomotor Symptom Diary. Our secondary aims are to compare the effects of three alternative treatments, HRT and placebo on: 1) vaginal cytology (vaginal maturation index); 2) serum lipids (total cholesterol, HDL and LDL cholesterol, triglycerides); 3) bone mineral density (hip and spine dual energy x-ray absorptiometry scan); 4) glucose metabolism (insulin, fasting blood glucose); and 5) coagulation factors (fibrinogen, PAI-1).

Our hypotheses are that compared to placebo, the three alternative treatments tested in this proposal will; reduce frequency of hot flashes and night sweats, improve vaginal maturation and decrease vagina atrophy as measured by maturation index, lower total cholesterol and LDL with no effect on HDL, reduce the rate of decline in bone mineral density (BMD), and have no effect on glucose metabolism or clotting factors.

To accomplish our specific aims we will: 1) recruit and randomize approximately peri- and post-women to one of 5 treatment arms for one year; 2) collect measurements of primary and secondary outcomes at baseline, 3, 6, and 12 months; and 3) compare changes in outcomes in the groups taking alternative treatments to those in the HRT and placebo groups.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Vasomotor Symptoms Associated With Menopause
Intervention  ICMJE
  • Drug: Black cohosh
  • Drug: Multibotanical preparation
  • Drug: Multibotanical preparation + dietary soy counseling
  • Drug: Conjugated equine estrogen +/- medroxyprogesterone acetate
Study Arms  ICMJE Not Provided
Publications * Newton KM, Reed SD, LaCroix AZ, Grothaus LC, Ehrlich K, Guiltinan J. Treatment of vasomotor symptoms of menopause with black cohosh, multibotanicals, soy, hormone therapy, or placebo: a randomized trial. Ann Intern Med. 2006 Dec 19;145(12):869-79.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE
 (submitted: September 12, 2005)
351
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE September 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 45 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00169299
Other Study ID Numbers  ICMJE R01AG017057( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Not Provided
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Kaiser Permanente
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • National Institute on Aging (NIA)
  • National Center for Complementary and Integrative Health (NCCIH)
Investigators  ICMJE
Principal Investigator: Katherine M Newton, PhD Group Health Cooperative, Center for Health Studies
PRS Account Kaiser Permanente
Verification Date September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP