Amino Acid Therapy for Hot Flashes in Postmenopausal Women

Phase 1

Completed

• Conditions: Hot Flashes

• Registration Number: NCT00081952
• Lead Sponsor: National Center for Complementary and Integrative Health (NCCIH)

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 Description

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.

Study Timeline

• Study Start: 2003-10
• Study First Submitted: 2004-04-27
• Study First Submitted QC: 2004-04-27
• Study First Posted: 2004-04-28
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-21
• Last Update Posted: 2013-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 15

Inclusion Criteria

• Postmenopausal
• Experience over 5 hot flashes per day

Exclusion Criteria

• Hormone Replacement Therapy (HRT) in the past 2 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (1)

Women's Health Initiative; 🇺🇸 Buffalo, New York, United States