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Sponsored by: |
University of California, San Francisco |
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Information provided by: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT00283192 |
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.
Condition | Intervention |
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Menopause-Hot Flashes |
Drug: Sertraline |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 100 |
Study Start Date: | July 2003 |
Estimated Study Completion Date: | January 2006 |
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.
Ages Eligible for Study: | 40 Years to 60 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
UCSF Women's Health Clinical Research Center | |
San Francisco, California, United States, 94115 |
Principal Investigator: | Deborah G Grady, MD, MPH | University of California, San Francisco |
Study ID Numbers: | H5287-23467-03, FAST |
Study First Received: | January 25, 2006 |
Last Updated: | August 2, 2006 |
ClinicalTrials.gov Identifier: | NCT00283192 |
Health Authority: | United States: Food and Drug Administration |
Menopausal Symptoms Hot flashes |
Signs and Symptoms Hot Flashes Sertraline Flushing |
Healthy Serotonin Menopause |
Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Serotonin Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Physiological Effects of Drugs |
Psychotropic Drugs Serotonin Uptake Inhibitors Central Nervous System Agents Pharmacologic Actions Antidepressive Agents |