Flushes and Sertraline Trial

This study has been completed.
Sponsor:
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00283192
First received: January 25, 2006
Last updated: August 2, 2006
Last verified: August 2005

January 25, 2006
August 2, 2006
July 2003
Not Provided
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
Same as current
Complete list of historical versions of study NCT00283192 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Menopause-Hot Flashes
Drug: Sertraline
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
January 2006
Not Provided

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”
Female
40 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00283192
H5287-23467-03, FAST
Not Provided
Not Provided
University of California, San Francisco
Not Provided
Principal Investigator: Deborah G Grady, MD, MPH University of California, San Francisco
University of California, San Francisco
August 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP