Amino Acid Therapy for Hot Flashes in Postmenopausal Women - Full Text View

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

MedlinePlus related topics:

Menopause

ChemIDplus related topics:

Amino acids, branched-chain Norleucine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

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

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

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

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

Postmenopause

Study placed in the following topic categories:

Signs and Symptoms

Hot Flashes

Additional relevant MeSH terms:

Pathological Conditions, Signs and Symptoms

ClinicalTrials.gov processed this record on May 11, 2008

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