MsFLASH-01: Escitalopram for Menopausal Symptoms in Midlife Women

Fred Hutchinson Cancer Center (FHCC)

Status

Completed

Conditions

Menopause

Vasomotor Symptoms

Hot Flashes

Treatments

Other: Placebo

Drug: Escitalopram

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00894543

1U01AG032699-01 (U.S. NIH Grant/Contract)

MsFLASH-01

1U01AG032656-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

205 patients

Sex

Female

Ages

40 to 62 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.