MsFLASH-01: Escitalopram for Menopausal Symptoms in Midlife Women

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00894543
Study type	Interventional
Source	Fred Hutchinson Cancer Research Center
Contact
Status	Completed
Phase	N/A
Start date	July 2009
Completion date	June 2010

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04553029` - A Survey Evaluating Prevalence, Severity and Associated Factors in East Asian Women With Moderate-to-severe Menopause-related Vasomotor Symptoms (MR-VMS)
Completed	`NCT03672513` - Short-term Supplementation, Bone Turnover and Antioxidant Status in Menopause	N/A
Terminated	`NCT03642119` - Validation of an Objective Instrument to Measure Hot Flashes During Menopause
Completed	`NCT05387174` - Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period	N/A
Completed	`NCT04210583` - RF and PEMF for Treatment of Vaginal Laxity and Mons Pubis and Labia for Improvement of Skin Laxity	N/A
Completed	`NCT06057896` - Effects of Combined Natural Molecules on Metabolic Syndrome in Menopausal Women
Completed	`NCT05617287` - An Exploratory Investigation of Dietary Supplementation and the Effect on Common Symptoms of Perimenopause and Menopause	N/A
Recruiting	`NCT05180266` - Therapeutic Touch and Music in The Menopausal Period	N/A
Recruiting	`NCT04043520` - Bioenergetic Effects of Aging and Menopause (BEAM)	Phase 4
Completed	`NCT03663075` - Effect of Group Education and Individual Counselling on Mental Health and Quality of Life in 45-60 Year Old Women	N/A
Completed	`NCT03363997` - Pharmacokinetics and Pharmacodynamics of 3 Dosages of Estriol After Continuous Vaginal Administration for 21 Days	Phase 1
Not yet recruiting	`NCT04728126` - Menopausal Symptoms and Burnout: Comparison of Occupational Health Issue Among Health Professionals in UMC Hospitals
Not yet recruiting	`NCT04724135` - Assessment of Menopause Related Quality of Life Among Health Professionals in University Hospitals of UMC in Nur-Sultan
Completed	`NCT02274571` - Raising Insulin Sensitivity in Post Menopause	Early Phase 1
Completed	`NCT02430987` - Low Sexual Desire and Metabolic Syndrome	N/A
Completed	`NCT02253173` - Estradiol Vaginal Softgel Capsules in Treating Symptoms of Vulvar and Vaginal Atrophy in Postmenopausal Women	Phase 3
Completed	`NCT01757340` - Calorie Restriction With Leucine Supplementation	N/A
Recruiting	`NCT01488903` - A Cohort Research of Genetic Susceptibility for Common Obesity in Women	N/A
Terminated	`NCT01633814` - Hormone Replacement and Neural Cardiovascular Control in Postmenopausal Women	N/A
Completed	`NCT00599456` - Investigation of the Usefulness of Omega 3 Vitamins in the Relief of Hot Flashes in Menopausal Women.	N/A