Status:
COMPLETED
MsFLASH-01: Escitalopram for Menopausal Symptoms in Midlife Women
Lead Sponsor:
Fred Hutchinson Cancer Center
Collaborating Sponsors:
National Institute on Aging (NIA)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Hot Flashes
Menopause
Eligibility:
FEMALE
40-62 years
Phase:
NA
Brief Summary
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 reupta...
Detailed Description
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 tria...
Eligibility Criteria
Inclusion
- 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, serotonin-norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (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.
Exclusion
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
205 Patients enrolled
Trial Details
Trial ID
NCT00894543
Start Date
July 1 2009
End Date
June 1 2010
Last Update
March 8 2013
Active Locations (5)
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1
Northern California Kaiser, Division of Research
Oakland, California, United States, 94612
2
Indiana University
Indianapolis, Indiana, United States, 46202
3
Massachusetts General Hospital, Harvard Medical School
Boston, Massachusetts, United States, 02114
4
Brigham and Women's Hospital
Chestnut Hill, Massachusetts, United States, 02467