Clinical Trial: Amino Acid Therapy for Hot Flashes in Postmenopausal Women

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Amino Acid Therapy for Hot Flashes/Postmenopausal Women

Brief Summary: 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.

Detailed 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.

Sponsor: National Center for Complementary and Integrative Health (NCCIH)

Current Primary Outcome:

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: National Center for Complementary and Integrative Health (NCCIH)

Dates:
Date Received: April 27, 2004
Date Started: October 2003
Date Completion:
Last Updated: March 21, 2013
Last Verified: March 2013