Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00429806
Status:
COMPLETED
Last Update Posted:
2017-04-07
First Post:
2007-01-31
Brief Title:
DHEA Bioavailability Following Administration of Vaginal Suppositories in Post-Menopausal Women With Vaginal Atrophy
Sponsor:
CHU de Quebec-Universite Laval
Organization:
CHU de Quebec-Universite Laval
Study Overview
Official Title:
DHEA Bioavailability Following Administration of Vaginal Suppositories in Post-Menopausal Women With Vaginal Atrophy-Phase I RandomizedPlacebo-Controlled Double-Blind Study
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 systemic bioavailability of DHEA and its metabolites and the pharmacokinetics of vaginal suppositories at four different DHEA concentration
Detailed Description:
Humans 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
Therefore this study proposes to evaluate the systemic bioavailability and the effectiveness of 13 mL vaginal suppositories of DHEA at 4 different concentrations 00 05 10 et 18 following 1 week administration of vaginal suppositories in post-menopausal women with vaginal atrophy This is a phase I randomized placebo-controlled double-blind study
Therefore this study proposes to evaluate the systemic bioavailability and the effectiveness of 13 mL vaginal suppositories of DHEA at 4 different concentrations 00 05 10 et 18 following 1 week administration of vaginal suppositories in post-menopausal women with vaginal atrophy This is a phase I randomized placebo-controlled double-blind study
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