Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00160173
Status:
COMPLETED
Last Update Posted:
2022-09-13
First Post:
2005-09-08
Brief Title:
Efficacy Study Comparing 09 g and 125 g Estrogel With Placebo for Vasomotor Symptoms and Vulvar and Vaginal Atrophy
Sponsor:
ASCEND Therapeutics
Organization:
ASCEND Therapeutics
Study Overview
Official Title:
Efficacy Study Comparing 09 g and 125 g EstroGel 003 Doses With Placebo in the Treatment of Vasomotor Symptoms and Vulvar and Vaginal Atrophy Associated With Menopause
Status:
COMPLETED
Status Verified Date:
2022-09
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:
This study is intended to establish the lowest effective dose of EstroGel for the treatment of vasomotor symptoms associated with menopause
Detailed Description:
The primary objective of this study was to establish the lowest effective dose of EstroGel for the treatment of vasomotor symptoms associated with menopause by comparing the efficacy of 09 g and 125 g EstroGel 003 doses with placebo Effects on symptoms of vulvar and vaginal atrophy were assessed as secondary efficacy parameters
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