Ignite Creation Date:
2024-05-05 @ 4:46 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00317148
Status:
COMPLETED
Last Update Posted:
2017-04-07
First Post:
2006-04-20
Brief Title:
Effect of Dehydroepiandrosterone DHEA on Hot Flashes in Postmenopausal Women
Sponsor:
CHU de Quebec-Universite Laval
Organization:
CHU de Quebec-Universite Laval
Study Overview
Official Title:
Phase II-III Placebo-Controlled Study to Evaluate the Effects of DHEA on Vasomotor Symptoms Hot Flashes in Postmenopausal Women
Status:
COMPLETED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to evaluate the effect of daily oral intake of DHEA 50 mg for 4 months on reducing vasomotor symptoms hot flashes compared to placebo administration in postmenopausal women
Detailed Description:
Humans along with the other primates are unique among animal species in having adrenals that secrete large amounts of the inactive precursor steroids dehydroepiandrosterone DHEA and especially its sulfate DHEA-S The marked reduction in the formation of DHEA-S by the adrenals during aging results in a dramatic fall in the formation of androgens and estrogens in peripheral target tissues a situation that has been proposed to be associated with age-related diseases including skin atrophy insulin resistance and obesity Much attention has been given to the benefits of DHEA administered to postmenopausal women especially on the bone skin vagina and well being after oral as well as percutaneous administration of the precursor steroid
This study proposes to study the effect of 50 mg oral DHEA capsules during a period of 4 months administered to postmenopausal women experiencing 50 or more moderate to severe hot flushes per week Participants will be stratified by the number of hot flushes experienced per week The two strata are 50-70 or more than 70 hot flushes per week During the study several biological and clinical parameters will be evaluated as well as the reduction of the number of hot flashes and improvement of overall quality of life
Subjects will be evaluated at specific time intervals during the study for the above mentioned parameters as well as tolerability and adverse reactions
This study proposes to study the effect of 50 mg oral DHEA capsules during a period of 4 months administered to postmenopausal women experiencing 50 or more moderate to severe hot flushes per week Participants will be stratified by the number of hot flushes experienced per week The two strata are 50-70 or more than 70 hot flushes per week During the study several biological and clinical parameters will be evaluated as well as the reduction of the number of hot flashes and improvement of overall quality of life
Subjects will be evaluated at specific time intervals during the study for the above mentioned parameters as well as tolerability and adverse reactions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None