Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00369434
Status:
COMPLETED
Last Update Posted:
2007-06-01
First Post:
2006-08-25
Brief Title:
Study of the Safety and Efficacy of Desvenlafaxine Succinate for Vasomotor Symptoms in Postmenopausal Women
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Organization:
Wyeth is now a wholly owned subsidiary of Pfizer
Study Overview
Official Title:
A Double-Blind Randomized Placebo-Controlled Efficacy and Safety Study of DVS SR for Treatment of Vasomotor Symptoms Associated With Menopause
Status:
COMPLETED
Status Verified Date:
2007-05
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 evaluate the efficacy and safety of 100 mg and 150 mg of DVS SR an extended release form of desvenlafaxine succinate in comparison to placebo for the treatment of Vasomotor Symptoms VMS associated with menopause in a population of postmenopausal women
Detailed Description:
To assess the efficacy and safety of 100 mg and 150 mg of DVS SR in comparison to placebo for the treatment of moderate to severe VMS associated with menopause as well as additional outcome indicators such as sleep disruptions overall climacteric symptoms mood changes somatic symptoms and overall satisfaction with DVS SR in postmenopausal women
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