Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00081952
Status:
COMPLETED
Last Update Posted:
2013-03-22
First Post:
2004-04-27
Brief Title:
Amino Acid Therapy for Hot Flashes in Postmenopausal Women
Sponsor:
National Center for Complementary and Integrative Health NCCIH
Organization:
National Center for Complementary and Integrative Health NCCIH
Study Overview
Official Title:
Amino Acid Therapy for Hot FlashesPostmenopausal Women
Status:
COMPLETED
Status Verified Date:
2013-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None