MsFLASH-01: Escitalopram for Menopausal Symptoms in Midlife Women
Information source: Fred Hutchinson Cancer Research Center
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hot Flashes; Menopause; Vasomotor Symptoms
Intervention: Escitalopram (Drug); Placebo (Other)
Phase: N/A
Status: Recruiting
Sponsored by: Fred Hutchinson Cancer Research Center Official(s) and/or principal investigator(s):
Ellen W Freeman, PhD, Principal Investigator, Affiliation: University of Pennsylvania Medical Center
Andrea Z LaCroix, PhD, Principal Investigator, Affiliation: Fred Hutchinson Cancer Research Center
Garnet L Anderson, PhD, Principal Investigator, Affiliation: Fred Hutchinson Cancer Research Center
Kris Ensrud, MD, Study Chair, Affiliation: University of Minnesota
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 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.
Clinical Details
Official title: Menopause Strategies: Finding Lasting Answers for Symptoms and Health: Efficacy of a Selective Serotonin Reuptake Inhibitor (SSRI) for Menopausal Symptoms in Midlife Women
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: The frequency and severity of menopausal hot flashes in response to SSRI treatment as escitalopram (Lexapro®) as measured twice daily on the hot flash diaries over a week.
Secondary outcome: Bothersomeness of hot flashes, menopausal stage, anxiety, depressed mood, sleep, perceived stress, sexual functioning, and pain.
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 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.
Eligibility
Minimum age: 40 Years.
Maximum age: 62 Years.
Gender(s): Female.
Criteria:
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.
Locations and Contacts
Northern California Kaiser, Division of Research, Oakland, California 94612, United States; Not yet recruiting
Melissa L Nelson, Phone: 510-891-3232, Email: Melissa.L.Nelson@nsmtp.kp.org
Teresa Picchi, Phone: 510-891-3246, Email: Teresa.Picchi@nsmtp.kp.org
Barbara Sternfeld, PhD, Principal Investigator
Bette Caan, DrPH, Principal Investigator
Indiana University, Indianapolis, Indiana 46202, United States; Recruiting
Jennifer Lynn Milata, Phone: 317-278-0853, Email: jelbray@iupui.edu
Jenni Markowitz, Phone: 317-278-6095, Email: jmarkowi@iupui.edu
Janet S Carpenter, RN, PhD, Principal Investigator
Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts 02114, United States; Recruiting
Amy Heberle, Phone: 617-724-6540, Email: aheberle@partners.org
Suzanna Fowler, Phone: 617-726-2912, Email: skfowler@partners.org
Lee Cohen, MD, Principal Investigator
Hadine Joffe, MD, Principal Investigator
Brigham and Women's Hospital, Chestnut Hill, Massachusetts 02467, United States; Recruiting
Janet Lieson, Phone: 617-732-9863, Email: jlieson@partners.org
Kate Kalan, Phone: 617-732-9871, Email: kkalan@partners.org
JoAnn Manson, MD, Principal Investigator
University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States; Recruiting
Nilma Dalal, Phone: 215-662-3329, Email: ndalal@obgyn.upenn.edu
Cheryl Irving, Phone: 215-662-3329, Email: cirving@mail.med.upenn.edu
Ellen W Freeman, PhD, Principal Investigator
Additional Information
Starting date: July 2009
Last updated: September 30, 2009
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