Amino Acid Therapy for Hot Flashes in Postmenopausal Women | NCT00081952

Studies
Amino Acid Therapy for Hot Flashes in Postmenopausal Women

NCT00081952

Sponsor

National Center for Complementary and Integrative Health (NCCIH)

Status

Completed

Last Update Posted

Mar 22, 2013Estimated

Enrollment

Phase

Phase 1Phase 2

Conditions

Hot Flashes

Interventions

L-norleucine

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Oct 2003

Primary Completion Date

Oct 2007Actual

Completion Date

Oct 2007Actual

First Submitted Date

Apr 27, 2004

First Submission Date that Met QC Criteria

Apr 27, 2004

First Posted Date

Apr 28, 2004Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 21, 2013

Last Update Posted Date

Mar 22, 2013Estimated

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
L-norleucine	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Postmenopausal
Experience over 5 hot flashes per day

Exclusion Criteria:

Hormone Replacement Therapy (HRT) in the past 2 months

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Thomas Guttuso, MD	Women's Health Initiative	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Women's Health Initiative		Buffalo	New York	14214	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18591315	Derived	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. doi: 10.1097/AOG.0b013e31817d53b6.

ID	Term
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D000614	Aminocaproates
D000596	Amino Acids
D000602	Amino Acids, Peptides, and Proteins