msflash-01: escitalopram for menopausal symptoms in midlife women

Conditions: Hot Flashes; Menopause; Vasomotor Symptoms

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.

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 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.

Keywords: hot flashes menopause vasomotor symptoms