MsFLASH-01: Escitalopram for Menopausal Symptoms in Midlife Women

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Fred Hutchinson Cancer Research Center
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Center for Complementary and Integrative Health (NCCIH); National Institute on Aging (NIA); Office of Research on Women's Health (ORWH)
• Treatments: Citalopram; Dexetimide; Serotonin; Serotonin Uptake Inhibitors

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.