N/A
N=205
MsFLASH-01: Escitalopram for Menopausal Symptoms in Midlife Women
Hot Flashes · Menopause · Vasomotor Symptoms
Bottom Line
View on ClinicalTrials.gov: NCT00894543 ↗Enrolled (actual)
205
Serious AEs
0.0%
Results posted
Mar 2011
Primary outcome: Primary: Daily Frequency of Hot Flashes Per Day Assessed by Prospective Daily Diaries — 9.88; 9.66 Hot flashes/day
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Escitalopram (Drug); Placebo (Other)
- Age
- Adult · 40+ yrs
- Sex
- Female
- Sponsor
- Fred Hutchinson Cancer Center
- Primary completion
- Jun 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Daily Frequency of Hot Flashes Per Day Assessed by Prospective Daily Diaries |
9.88; 9.66 | — |
| PRIMARY Change in Daily Frequency of Hot Flashes Between Baseline and Week 4 as Assessed by Prospective Daily Diaries |
-4.37; -2.49 | — |
| PRIMARY Change in Daily Frequency of Hot Flashes Between Baseline and Week 8 as Assessed by Prospective Daily Diaries |
-4.60; -3.20 | <0.001 sig |
| PRIMARY Daily Severity of Hot Flashes Assessed by Prospective Daily Diaries |
2.16; 2.19 | — |
| PRIMARY Change in Daily Severity of Hot Flashes Between Baseline and Week 4 as Assessed by Prospective Daily Diaries |
-0.43; -0.23 | — |
| PRIMARY Change in Daily Severity of Hot Flashes Between Baseline and Week 8 as Assessed by Prospective Daily Diaries |
-0.53; -0.30 | <0.001 sig |
| SECONDARY Daily Hot Flash Bother, Recorded on Daily Diaries |
3.12; 3.16 | — |
| SECONDARY Change in Daily Hot Flash Bother Between Baseline and Week 4 as Recorded on Daily Diaries |
-0.59; -0.29 | — |
| SECONDARY Secondary Outcome: Change in Daily Hot Flash Bother Between Baseline and Week 8 as Recorded on Daily Diaries |
-0.63; -0.39 | 0.001 sig |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00894543). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.