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MsFLASH-01: Escitalopram for Menopausal Symptoms in Midlife Women

Information source: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hot Flashes; Menopause; Vasomotor Symptoms

Intervention: Escitalopram (Drug); Placebo (Other)

Phase: N/A

Status: Completed

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 - Clinical and Translational Science Institute

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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Daily Frequency of Hot Flashes Per Day Assessed by Prospective Daily Diaries

Change in Daily Frequency of Hot Flashes Between Baseline and Week 4 as Assessed by Prospective Daily Diaries

Change in Daily Frequency of Hot Flashes Between Baseline and Week 8 as Assessed by Prospective Daily Diaries

Daily Severity of Hot Flashes Assessed by Prospective Daily Diaries

Change in Daily Severity of Hot Flashes Between Baseline and Week 4 as Assessed by Prospective Daily Diaries

Change in Daily Severity of Hot Flashes Between Baseline and Week 8 as Assessed by Prospective Daily Diaries

Secondary outcome:

Daily Hot Flash Bother, Recorded on Daily Diaries

Change in Daily Hot Flash Bother Between Baseline and Week 4 as Recorded on Daily Diaries

Secondary Outcome: Change in Daily Hot Flash Bother Between Baseline and Week 8 as Recorded on Daily Diaries

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, 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.

Locations and Contacts

Northern California Kaiser, Division of Research, Oakland, California 94612, United States

Indiana University, Indianapolis, Indiana 46202, United States

Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts 02114, United States

Brigham and Women's Hospital, Chestnut Hill, Massachusetts 02467, United States

University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States

Additional Information

MsFLASH Participant Website

Starting date: July 2009
Last updated: March 5, 2013

Page last updated: August 23, 2015

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