Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00283192
Status:
COMPLETED
Last Update Posted:
2006-08-04
First Post:
2006-01-25
Brief Title:
Flushes and Sertraline Trial
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
A Randomized Double-Blinded Placebo Controlled Trial of the Effect of Sertraline Vs Placebo in Reducing the Incidence and Severity of Hot Flashes in Healthy Women
Status:
COMPLETED
Status Verified Date:
2005-08
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 primary outcome of FAST a randomized double-blinded placebo controlled trial of the effect of sertraline vs placebo in reducing the incidence and severity of hot flushes in healthy women is to determine if 6 weeks of treatment with sertraline 50mg daily for 2 weeks followed by 100mg per day for 4 weeks if tolerated results in a greater reduction in hot flush score frequency severity compared to placebo among women with moderate to severe hot flashes The secondary aim is to determine the effect of treatment with sertraline on quality of life sleep sexual function and mood
Detailed Description:
The primary aim of FAST is to determine if 6 weeks of treatment with sertraline 50 mg daily for 2 weeks followed by 100 mg per day for 4 weeks if tolerated results in greater reduction in hot flush score frequency x severity frequency and severity compared to placebo among women with moderate to severe hot flushes
The Secondary AimsTo determine the effect of treatment with sertraline on quality of life sleep sexual function mood and cognitive function To determine if a modified short version of a sexual function instrument is valid
The Secondary AimsTo determine the effect of treatment with sertraline on quality of life sleep sexual function mood and cognitive function To determine if a modified short version of a sexual function instrument is valid
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| FAST | None | None | None |