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View Clinical Trial (Medical Research Study)
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MsFLASH-01: Escitalopram for Menopausal Symptoms in Midlife Women - NCT00894543-02467 (Clinical Trial 290481)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy290481.aspx
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| City: |
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Chestnut Hill |
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State:
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MA |
| Zip Code: |
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02467 |
| Conditions: |
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Hot Flashes - Menopause - Vasomotor Symptoms |
| Purpose: |
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The purpose of this study is to test whether a medication reduces the number, severity and
bothersomeness of menopausal hot flashes. Escitalopram (also called Lexapro®) is a
selective serotonin reuptake inhibitor (SSRI). It is sold by prescription for depression
and general anxiety disorder. An SSRI increases serotonin, a brain substance that is
believed to influence mood. Serotonin may also affect brain levels of estradiol, a hormone
related to hot flashes. This research study will test whether escitalopram reduces
menopausal hot flashes.
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| Study summary: |
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The MsFLASH-01 study, Efficacy of a Selective Serotonin Reuptake Inhibitor (SSRI) for
Menopausal Symptoms in Midlife Women is a randomized, double-blind, placebo-controlled,
parallel arm clinical trial. The design includes: 3 weeks of daily recording of hot flashes
prior to drug treatment; 8 weeks of double-blind treatment with escitalopram or placebo with
dose escalation at 4 weeks among non-responders; 1 week of drug taper for those on higher
dose, followed by 2 weeks with no treatment; and a telephone follow-up post-treatment. This
study is one of five clinical trials to be conducted as part of the Menopause Strategies -
Finding Lasting Answers for Symptoms and Health (MsFLASH) study, a network of investigators
and clinical trials designed to find new ways to alleviate the most common, bothersome
symptoms of the menopausal transition. |
| Criteria: |
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Inclusion Criteria, Common to all MsFLASH Studies:
- Females aged 40-62 years.
- Menopausal, including:
- Women with a uterus who have skipped 2 or more menstrual cycles with an
amenorrhea interval ≥60 days in the past 12 months.
- Women who have had a bi-lateral oophorectomy (surgical removal of both ovaries).
- Women without a uterus who still have ovaries, under certain conditions
determined during screening.
- Having bothersome hot flashes.
- In general good health as determined by medical history and physical measures.
- Signed informed consent.
Exclusion Criteria, Common to all MsFLASH Studies:
- Use of hormone therapy or hormonal contraceptives during the 2 months before
enrollment and for the duration of the study. Certain exceptions apply, determined
during screening.
- Use of any other therapy that is taken specifically for hot flashes, including
prescription, over-the-counter, or herbal therapies in the past month and duration of
the study.
- Any current severe or unstable medical illness.
- Uncontrolled hypertension (>160/100) or resting heart rate >110.
- History of endometrial or ovarian cancer; MI, angina, or cerebrovascular events.
- Pregnancy, intending pregnancy, breast feeding.
- Current participation in another drug trial or intervention study.
- Inability or unwillingness to complete the study procedures.
- Certain other conditions, determined during screening.
Exclusion Criteria, Specific to MsFLASH-01:
- Use of selective estrogen receptor modulators (SERMS) or aromatase inhibitors during
the two months before enrollment.
- Use of gabapentin, pregabalin, triptans, warfarin (Coumadin®), or St. John's Wort.
- Known hypersensitivity to escitalopram (Lexapro®) or citalopram (Celexa®).
- Use of antidepressants during the past 30 days before starting Study 01, including
SSRIs, SNRIs, MAOIs, and anxiolytics.
- Not using a medically approved method of birth control, if sexually active and not 12
or more months since last menstrual period.
- History of liver, gall bladder, renal disease, or uncontrolled seizure disorder.
- Certain other conditions, determined during screening. |
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| Study is available at: |
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Brigham and Women's Hospital
Chestnut Hill, MA 02467
United States
Primary Contact:
Janet Lieson
Email: jlieson@partners.org
Phone: 617-732-9863 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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February 17, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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