Expired Study
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Buffalo, New York 14214


Purpose:

The purpose of this study is to determine the safety, tolerability, and effectiveness of the amino acid L-isoleucine in the treatment of hot flashes in postmenopausal women.


Study summary:

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-isoleucine 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-isoleucine 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-isoleucine 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.


Criteria:

Inclusion Criteria: - Postmenopausal - Experience over 5 hot flashes per day Exclusion Criteria: - Hormone Replacement Therapy (HRT) in the past 2 months


NCT ID:

NCT00081952


Primary Contact:

Principal Investigator
Thomas Guttuso, MD
Women's Health Initiative


Backup Contact:

N/A


Location Contact:

Buffalo, New York 14214
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 11, 2017

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