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Menopause Strategies: Finding Lasting Answers for Symptoms and Health: Efficacy of a Selective Serotonin Reuptake Inhibitor (SSRI) for Menopausal Symptoms in Midlife Women


N/A
40 Years
62 Years
Not Enrolling
Female
Hot Flashes, Menopause, Vasomotor Symptoms

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Trial Information

Menopause Strategies: Finding Lasting Answers for Symptoms and Health: Efficacy of a Selective Serotonin Reuptake Inhibitor (SSRI) for Menopausal Symptoms in Midlife Women


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.

Inclusion 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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Description:

Baseline hot flash frequency per day was calculated as the daily mean of the daily totals reported during the first two screening weeks.

Outcome Time Frame:

Baseline

Safety Issue:

No

Principal Investigator

Ellen W Freeman, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pennsylvania Medical Center

Authority:

United States: Federal Government

Study ID:

MsFLASH-01

NCT ID:

NCT00894543

Start Date:

July 2009

Completion Date:

June 2010

Related Keywords:

  • Hot Flashes
  • Menopause
  • Vasomotor Symptoms
  • Hot flashes
  • Menopause
  • Vasomotor symptoms
  • Hot Flashes

Name

Location

Brigham and Women's HospitalBoston, Massachusetts  02115
University of PennsylvaniaPhiladelphia, Pennsylvania  19104
Indiana UniversityIndianapolis, Indiana  46202
Northern California Kaiser, Division of ResearchOakland, California  94612
Massachusetts General Hospital, Harvard Medical SchoolBoston, Massachusetts  02114