Flushes and Sertraline Trial

NCT ID: NCT00283192

Last Updated: 2006-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-07-31
• Study Completion Date: 2006-01-31

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.

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

Keywords

Menopausal Symptoms; Hot flashes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Sertraline

Intervention Type: DRUG

Eligibility Criteria

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

• 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"

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Principal Investigators

Deborah G Grady, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

UCSF Women's Health Clinical Research Center

San Francisco, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 17400842 (View on PubMed)

Other Identifiers

FAST

Identifier Type: -

Identifier Source: secondary_id

H5287-23467-03

Identifier Type: -

Identifier Source: org_study_id