NCT00081952

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2003

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 28, 2004

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

March 22, 2013

Status Verified

March 1, 2013

Enrollment Period

4 years

First QC Date

April 27, 2004

Last Update Submit

March 21, 2013

Conditions

Hot Flashes

Keywords

Postmenopause

Interventions

L-norleucineDRUG

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Postmenopausal
  • Experience over 5 hot flashes per day

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women's Health Initiative

Buffalo, New York, 14214, United States

Location

Related Publications (1)

  • 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.

    PMID: 18591315DERIVED

MeSH Terms

Conditions

Hot Flashes

Interventions

Norleucine

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AminocaproatesAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Thomas Guttuso, MD

    Women's Health Initiative

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2004

First Posted

April 28, 2004

Study Start

October 1, 2003

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

March 22, 2013

Record last verified: 2013-03

Locations

US(1)