Amino Acid Therapy for Hot Flashes in Postmenopausal Women - Tabular View

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Amino Acid Therapy for Hot Flashes in Postmenopausal Women

This study has been completed.
Information provided by National Center for Complementary and Alternative Medicine (NCCAM)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Amino Acid Therapy for Hot Flashes in Postmenopausal Women

Official Title ^†

Amino Acid Therapy for Hot Flashes/Postmenopausal Women

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 Phase

Phase I, Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Primary Outcome Measure ^†

Secondary Outcome Measure ^†

Condition ^†

Hot Flashes

Intervention ^†

Drug: L-norleucine

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

Start Date ^†

October 2003

Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

Postmenopausal
Experience over 5 hot flashes per day

Exclusion Criteria:

Hormone Replacement Therapy (HRT) in the past 2 months

Gender

Female

Ages

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00081952

Organization ID

K23 AT001709-01

Secondary IDs ^††

Study Sponsor ^†

National Center for Complementary and Alternative Medicine (NCCAM)

Collaborators ^††

Investigators ^†

Principal Investigator:

Thomas Guttuso, MD

Women's Health Initiative

Information Provided By

National Center for Complementary and Alternative Medicine (NCCAM)

Verification Date

March 2006

First Received Date ^†

April 27, 2004

Last Updated Date

August 17, 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.