NCT00283192

Flushes and Sertraline Trial

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (planned)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: Female
• Age: 40 Years – 60 Years
• Healthy volunteers: Accepted

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 Aims:To 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.

Conditions

• Menopause-Hot Flashes

Interventions

Type	Name	Description
DRUG	Sertraline

Timeline

• Start date: 2003-07-01
• Completion: 2006-01-01
• First posted: 2006-01-27
• Last updated: 2006-08-04

Locations

1 site across 1 country: United States