Amino Acid Therapy for Hot Flashes in Postmenopausal Women

National Institutes of Health (NIH)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Hot Flashes

Treatments: Drug: L-norleucine

Study type: Interventional

Funder types: NIH

Identifiers

NCT00081952

K23AT001709-01

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Postmenopausal
• Experience over 5 hot flashes per day

Exclusion criteria

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