MsFLASH-01: Escitalopram for Menopausal Symptoms in Midlife Women

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.

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.