MsFLASH-01: Escitalopram for Menopausal Symptoms in Midlife Women - Full Text View

Sponsor:	Fred Hutchinson Cancer Research Center
Collaborators:	National Institute on Aging (NIA) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Center for Complementary and Alternative Medicine (NCCAM) Office of Research on Women's Health (ORWH)
Information provided by:	Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:	NCT00894543

Purpose

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.

Condition	Intervention
Hot Flashes Menopause Vasomotor Symptoms	Drug: Escitalopram Other: Placebo

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Menopause

Drug Information available for: Serotonin Benzetimide Dexetimide Citalopram hydrobromide Citalopram Escitalopram Escitalopram oxalate

U.S. FDA Resources

Further study details as provided by Fred Hutchinson Cancer Research Center:

Primary Outcome Measures:

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. [ Time Frame: 8-11 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Bothersomeness of hot flashes, menopausal stage, anxiety, depressed mood, sleep, perceived stress, sexual functioning, and pain. [ Time Frame: 8-11 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	July 2009
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Escitalopram: Active Comparator Escitalopram is a selective serotonin reuptake inhibitor (SSRI)	Drug: Escitalopram 10 mg (1 pill) escitalopram daily for the first four weeks. Dose increased to 20 mg (2 pills) escitalopram daily if relief from hot flashes has not occurred during the first four weeks of the daily 10 mg dose.
Placebo: Placebo Comparator Inactive pill	Other: Placebo Inactive pill (1 pill or 2 pills) daily for the 8-11 weeks of the trial.

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

Ages Eligible for Study:	40 Years to 62 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00894543

Locations

United States, California
Northern California Kaiser, Division of Research	Recruiting
Oakland, California, United States, 94612
Contact: Melissa L Nelson 510-891-3232 Melissa.L.Nelson@nsmtp.kp.org
Contact: Teresa Picchi 510-891-3246 Teresa.Picchi@nsmtp.kp.org
Principal Investigator: Barbara Sternfeld, PhD
Principal Investigator: Bette Caan, DrPH
United States, Indiana
Indiana University	Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Coral Smith, MSN, RN 317-278-0853 smith259@iupui.edu
Contact: Jenni Markowitz 317-278-6095 jmarkowi@iupui.edu
Principal Investigator: Janet S Carpenter, RN, PhD
United States, Massachusetts
Massachusetts General Hospital, Harvard Medical School	Recruiting
Boston, Massachusetts, United States, 02114
Contact: Amy Heberle 617-724-6540 aheberle@partners.org
Contact: Suzanna Fowler 617-726-2912 skfowler@partners.org
Principal Investigator: Lee Cohen, MD
Principal Investigator: Hadine Joffe, MD
Brigham and Women's Hospital	Recruiting
Chestnut Hill, Massachusetts, United States, 02467
Contact: Janet Lieson 617-732-9863 jlieson@partners.org
Contact: Kate Kalan 617-732-9871 kkalan@partners.org
Principal Investigator: JoAnn Manson, MD
United States, Pennsylvania
University of Pennsylvania	Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Maya Pandurangi 215-662-3329 mayapa@mail.med.upenn.edu
Contact: Cheryl Irving 215-662-3329 cirving@mail.med.upenn.edu
Principal Investigator: Ellen W Freeman, PhD

Sponsors and Collaborators

Fred Hutchinson Cancer Research Center

National Institute on Aging (NIA)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

National Center for Complementary and Alternative Medicine (NCCAM)

Office of Research on Women's Health (ORWH)

Investigators

Principal Investigator:	Ellen W Freeman, PhD	University of Pennsylvania Medical Center
Principal Investigator:	Andrea Z LaCroix, PhD	Fred Hutchinson Cancer Research Center
Principal Investigator:	Garnet L Anderson, PhD	Fred Hutchinson Cancer Research Center
Study Chair:	Kris Ensrud, MD	University of Minnesota - Clinical and Translational Science Institute

More Information

No publications provided

Responsible Party:	Fred Hutchinson Cancer Research Center ( Andrea LaCroix, Garnet Anderson )
Study ID Numbers:	MsFLASH-01, 1 U01 AG032699-01, 1 U01 AG032656-01
Study First Received:	May 5, 2009
Last Updated:	February 1, 2010
ClinicalTrials.gov Identifier:	NCT00894543 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Fred Hutchinson Cancer Research Center:

Hot flashes
Menopause
Vasomotor symptoms

Additional relevant MeSH terms:

Parasympatholytics
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Hot Flashes
Antiparkinson Agents
Cholinergic Agents
Citalopram

Serotonin Uptake Inhibitors
Pharmacologic Actions
Muscarinic Antagonists
Signs and Symptoms
Serotonin Agents
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Antidepressive Agents, Second-Generation
Dexetimide
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on February 08, 2010