Back to resultsAmino Acid Therapy for Hot Flashes in Postmenopausal Women
Primary Purpose
Hot Flashes
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
L-norleucine
Sponsored by
About this trial
This is an interventional treatment trial for Hot Flashes focused on measuring Postmenopause
Eligibility Criteria
Inclusion Criteria: Postmenopausal Experience over 5 hot flashes per day Exclusion Criteria: Hormone Replacement Therapy (HRT) in the past 2 months
Sites / Locations
- Women's Health Initiative
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00081952
First Posted
April 27, 2004
Last Updated
March 21, 2013
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT00081952
Brief Title
Amino Acid Therapy for Hot Flashes in Postmenopausal Women
Official Title
Amino Acid Therapy for Hot Flashes/Postmenopausal Women
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hot Flashes
Keywords
Postmenopause
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Allocation
Randomized
Enrollment
15 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
L-norleucine
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Postmenopausal
Experience over 5 hot flashes per day
Exclusion Criteria:
Hormone Replacement Therapy (HRT) in the past 2 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Guttuso, MD
Organizational Affiliation
Women's Health Initiative
Official's Role
Principal Investigator
Facility Information:
Facility Name
Women's Health Initiative
City
Buffalo
State/Province
New York
ZIP/Postal Code
14214
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
18591315
Citation
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.
Results Reference
derived
Learn more about this trial
Amino Acid Therapy for Hot Flashes in Postmenopausal Women
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