Amino Acid Therapy for Hot Flashes in Postmenopausal Women

This study has been completed.

First Received: April 27, 2004 Last Updated: August 17, 2006 History of Changes

Sponsor:	National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:	National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:	NCT00081952

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.

Condition	Intervention	Phase
Hot Flashes	Drug: L-norleucine	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	Amino Acid Therapy for Hot Flashes/Postmenopausal Women

Resource links provided by NLM:

Drug Information available for: Amino acids, branched-chain Norleucine

U.S. FDA Resources

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Estimated Enrollment:	15
Study Start Date:	October 2003

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.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Postmenopausal
Experience over 5 hot flashes per day

Exclusion Criteria:

Hormone Replacement Therapy (HRT) in the past 2 months

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00081952

Locations

United States, New York
Women's Health Initiative
Buffalo, New York, United States, 14214

Sponsors and Collaborators

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators

Principal Investigator:

Thomas Guttuso, MD

Women's Health Initiative

More Information

No publications provided by National Center for Complementary and Alternative Medicine (NCCAM)

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Guttuso T, McDermott MP, Su H, Kieburtz K. Effects of L-isoleucine and L-valine on hot flushes and serum homocysteine: a randomized controlled trial. Obstet Gynecol. 2008 Jul;112(1):109-15.

Study ID Numbers:	K23 AT001709-01
Study First Received:	April 27, 2004
Last Updated:	August 17, 2006
ClinicalTrials.gov Identifier:	NCT00081952 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):

Postmenopause

Additional relevant MeSH terms:

Signs and Symptoms
Hot Flashes

ClinicalTrials.gov processed this record on November 09, 2009