MsFLASH-01: Escitalopram for Menopausal Symptoms in Midlife Women

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”

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.

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.

Intervention(s) in this Clinical Trial

• 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.
• Other: Placebo
  • Inactive pill (1 pill or 2 pills) daily for the 8-11 weeks of the trial.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Escitalopram
  • Escitalopram is a selective serotonin reuptake inhibitor (SSRI)
• Placebo Comparator: Placebo
  • Inactive pill

Primary Measures

• Daily Frequency of Hot Flashes Per Day Assessed by Prospective Daily Diaries
  • Time Frame: Baseline
    Safety Issue?: No
• Change in Daily Frequency of Hot Flashes Between Baseline and Week 4 as Assessed by Prospective Daily Diaries
  • Time Frame: week 4 minus baseline
    Safety Issue?: No
• Change in Daily Frequency of Hot Flashes Between Baseline and Week 8 as Assessed by Prospective Daily Diaries
  • Time Frame: week 8 minus baseline
    Safety Issue?: No
• Daily Severity of Hot Flashes Assessed by Prospective Daily Diaries
  • Time Frame: Baseline
    Safety Issue?: No
• Change in Daily Severity of Hot Flashes Between Baseline and Week 4 as Assessed by Prospective Daily Diaries
  • Time Frame: week 4 minus baseline
    Safety Issue?: No
• Change in Daily Severity of Hot Flashes Between Baseline and Week 8 as Assessed by Prospective Daily Diaries
  • Time Frame: week 8 minus baseline
    Safety Issue?: No

Secondary Measures

• Daily Hot Flash Bother, Recorded on Daily Diaries
  • Time Frame: Baseline
    Safety Issue?: No
• Change in Daily Hot Flash Bother Between Baseline and Week 4 as Recorded on Daily Diaries
  • Time Frame: week 4 minus baseline
    Safety Issue?: No
• Secondary Outcome: Change in Daily Hot Flash Bother Between Baseline and Week 8 as Recorded on Daily Diaries
  • Time Frame: week 8 minus baseline
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: 62 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: Fred Hutchinson Cancer Research Center Other

Overall Clinical Trial Officials and Contacts

Ellen W Freeman, PhD Principal Investigator University of Pennsylvania Medical Center  

Information obtained from ClinicalTrials.gov on February 02, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00894543

Study ID Number: MsFLASH-01

ClinicalTrials.gov Identifier: NCT00894543

Health Authority: United States: Federal Government

MsFLASH Participant Website