Menopause-Hot FlashesNCT00283192
Flushes and Sertraline Trial
A study testing Sertraline in people with Menopause-Hot Flashes, run by University of California, San Francisco at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause-Hot Flashes
- What is being tested?
- Sertraline
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2003to Jan 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 40 - 60 years old
- Report > 14 hot flushes per week
- Willing to be randomized to sertraline or placebo
- Sign informed consent
Who cannot join
- 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)
Show all 13Show fewer
- 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"
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Women's Health Clinical Research Center
San Francisco, California, 94115
About this study
Official title: 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.
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.
- Conditions
- Menopause-Hot Flashes
- Being tested
- Sertraline
- Keywords
- Menopausal Symptoms, Hot flashes
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SertralineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2006 (estimated)
- Study startJul 2003
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Menopause-Hot FlashesStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Investigators
- Deborah G Grady, MD, MPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00283192
- Sponsor's protocol ID
- H5287-23467-03
- Other IDs
- FAST
- Status last verified
- Aug 2005
- First submitted
- 25 Jan 2006
- Last updated
- 4 Aug 2006
- Results posted
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00283192
- Acronym / sponsor ID
- H5287-23467-03
- Conditions
- Menopause-Hot Flashes
- Keywords
- Menopausal Symptoms, Hot flashes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Jul 2003
- Study completion
- Jan 2006
- First posted
- 27 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 40 - 60 years old
- Report > 14 hot flushes per week
- Willing to be randomized to sertraline or placebo
- Sign informed consent
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sertraline | Drug | – |
Primary outcome
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
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2006.
- Derived from this study: PubMed 17400842Grady 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah G Grady, MD, MPH principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sertraline in people with Menopause-Hot Flashes, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00283192, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2006.