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Amino Acid Therapy for Hot Flashes in Postmenopausal Women



Amino Acid Therapy for Hot Flashes in Postmenopausal Women

For Condition: Hot Flashes
Status: No longer recruiting
Sponsor(s): National Center for Complementary and Alternative Medicine (NCCAM) ,
Synopsis: The purpose of this study is to determine the safety, tolerability, and effectiveness of the amino acid L-norleucine in the treatment of hot flashes in postmenopausal women.
Details: Hot flashes affect approximately 75% of postmenopausal women. Although hormone replacement therapy (HRT) is highly effective in reducing hot flashes, long-term HRT is associated with increased rates of breast cancer and heart disease. Safe, effective, and well-tolerated hot flash therapies are needed. The amino acids L-methionine and L-norleucine have produced reductions in hot flash frequency. However, long-term L-methionine therapy may increase cardiovascular risks. This study will evaluate the short-term effects of L-norleucine therapy. Data from this study will be used to conduct long-term studies in the future. Participants in this study will be randomly assigned to receive one of two different L-norleucine doses for 2 weeks. Clinic visits will be made at baseline, Week 1, and Week 10. Participants will record the frequency and severity of their hot flashes in a diary.
Eligibility:
Study Type:
  Interventional, Treatment, Randomized, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: /
Genders: Female
Protocol Entry Criteria: Inclusion Criteria: - Postmenopausal - Experience over 5 hot flashes per day Exclusion Criteria: - Hormone Replacement Therapy (HRT) in the past 2 months
Total Enrollment: 15

Location and Contact Information:

Women's Health Initiative
Buffalo,  New York,  14214
United States
 


Additional Information:
Study ID Numbers:
  1-K23-AT001709-01; 
Study Start Date: October 2003
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00081952

Other Hot Flashes Studies:
1. Hormone Replacement Therapy for Hot Flashes and/or Vaginal Symptoms in Postmenopausal Women Receiving Tamoxifen for Breast Cancer

2. Black Cohosh Extract in Postmenopausal Breast Health

3. Alternative Therapies for Menopause: A Randomized Trial

4. Medroxyprogesterone Compared With Venlafaxine in Treating Hot Flashes in Women

5. Amino Acid Therapy for Hot Flashes in Postmenopausal Women

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