Status:
COMPLETED
Flushes and Sertraline Trial
Lead Sponsor:
University of California, San Francisco
Conditions:
Menopause-Hot Flashes
Eligibility:
FEMALE
40-60 years
Phase:
NA
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 t...
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 flus...
Eligibility Criteria
Inclusion
- Age 40 - 60 years old
- Report \> 14 hot flushes per week
- Willing to be randomized to sertraline or placebo
- Sign informed consent
Exclusion
- 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"
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
End Date :
January 1 2006
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00283192
Start Date
July 1 2003
End Date
January 1 2006
Last Update
August 4 2006
Active Locations (1)
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1
UCSF Women's Health Clinical Research Center
San Francisco, California, United States, 94115