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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. Gabapentin For the Control of Hot Flashes in Women With Breast Cancer

2. Goserelin in Preventing Ovarian Failure in Women Receiving Adjuvant Chemotherapy for Breast Cancer

3. Cyproterone Acetate in Treating Hot Flashes Following Surgical or Chemical Castration for Prostate Cancer

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

5. Black Cohosh in Treating Hot Flashes in Women Who Have or Who Are At Risk of Developing Breast Cancer

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Amino Acid Therapy for Hot Flashes in Postmenopausal Women

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