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CompletedNCT00283192Updated Aug 4, 2006

Flushes and Sertraline Trial

An interventional study of Sertraline in Menopause-Hot Flashes, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to female participants aged 40 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2006-08-04.

Sponsored by University of California, San Francisco · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
40 Years to 60 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Menopause-Hot Flashes

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Keywords

  • Menopausal Symptoms
  • Hot flashes
03

In context

Hot Flashes

285 studies on the registry are indexed under Hot Flashes; 50 are open to participants now.

This study's enrollment of 100 is above the median of 90 across 255 interventional studies indexed under Hot Flashes.

Browse Hot Flashes studies →

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.

Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Age 40 - 60 years old
  • Report > 14 hot flushes per week
  • Willing to be randomized to sertraline or placebo
  • Sign informed consent

Exclusion criteria

Exclusion Criteria:

  • 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"
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
100 participants

Interventions

  • DrugSertraline
06

What researchers measure

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.

07

Study locations

1 site
  • UCSF Women's Health Clinical Research Center
    San Francisco, California 94115, United States
08

References and documents

Publications

  • 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. PubMed 17400842 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 4, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00283192
Lead sponsor
University of California, San Francisco
First posted
Jan 27, 2006
Start date
Jul 2003
Completion
Jan 2006
Last update
Aug 4, 2006

Study contacts

Deborah G Grady, MD, MPH
principal investigator · University of California, San Francisco
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2005. You cannot join it, but the record below documents what was studied.

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