NCT00081952

Amino Acid Therapy for Hot Flashes in Postmenopausal Women

Amino Acid Therapy for Hot Flashes/Postmenopausal Women

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 15 (planned)
• Sponsor: National Center for Complementary and Integrative Health (NCCIH) · NIH
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Hot Flashes

Interventions

Type	Name	Description
DRUG	L-norleucine

Timeline

• Start date: 2003-10-01
• Primary completion: 2007-10-01
• Completion: 2007-10-01
• First posted: 2004-04-28
• Last updated: 2013-03-22

Locations

1 site across 1 country: United States