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
2 other identifiers
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2003
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 25, 2006
CompletedFirst Posted
Study publicly available on registry
January 27, 2006
CompletedAugust 4, 2006
August 1, 2005
January 25, 2006
August 2, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
To determine the effect of treatment with sertraline on quality of life, sleep, sexual function, and mood. To determine if a modified, short version of a sexual function instrument is valid.
Interventions
Eligibility Criteria
You may qualify if:
- Age 40 - 60 years old
- Report \> 14 hot flushes per week
- Willing to be randomized to sertraline or placebo
- Sign informed consent
You may not qualify if:
- History of bilateral oophorectomy
- Breast or ovarian cancer
- Liver disease
- Kidney disease requiring dialysis
- History of major depression (reported history of depression requiring therapy, hospitalization for depression, taking antidepressant drugs, history of suicide attempt)
- History of bipolar affective disorder (reported history of bipolar disorder requiring therapy, medications, hospitalized for bipolar disorder)
- Seizure disorder
- History of hypersensitivity to sertraline or to SSRIs
- Pregnancy or breast feeding
- Any medical or psychiatric condition which, in the investigator's opinion, would preclude the participant from adhering to the protocol or completing the trial;
- No estrogens or progestins for 3 months prior to screening or during enrollment
- Selective estrogen receptor modulators (SERMS)
- The following medications: clonidine, gabapentin, tricyclic antidepressants, monoamine oxidase (MAO) inhibitors, selective serotonin reuptake inhibitors (SSRIs), megesterol , oral contraceptives, androgens; and medications that are listed on the Pfizer Pharmaceutical drug insert as "contraindicated"
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UCSF Women's Health Clinical Research Center
San Francisco, California, 94115, United States
Related Publications (1)
Grady D, Cohen B, Tice J, Kristof M, Olyaie A, Sawaya GF. Ineffectiveness of sertraline for treatment of menopausal hot flushes: a randomized controlled trial. Obstet Gynecol. 2007 Apr;109(4):823-30. doi: 10.1097/01.AOG.0000258278.73505.fa.
PMID: 17400842DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Deborah G Grady, MD, MPH
University of California, San Francisco
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 25, 2006
First Posted
January 27, 2006
Study Start
July 1, 2003
Study Completion
January 1, 2006
Last Updated
August 4, 2006
Record last verified: 2005-08