Menopause Strategies: Finding Lasting Answers for Symptoms and Health: Efficacy of a Selective Serotonin Reuptake Inhibitor (SSRI) for Menopausal Symptoms in Midlife Women
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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Daily Frequency of Hot Flashes Per Day Assessed by Prospective Daily Diaries
Baseline hot flash frequency per day was calculated as the daily mean of the daily totals reported during the first two screening weeks.
Baseline
No
Ellen W Freeman, PhD
Principal Investigator
University of Pennsylvania Medical Center
United States: Federal Government
MsFLASH-01
NCT00894543
July 2009
June 2010
Name | Location |
---|---|
Brigham and Women's Hospital | Boston, Massachusetts 02115 |
University of Pennsylvania | Philadelphia, Pennsylvania 19104 |
Indiana University | Indianapolis, Indiana 46202 |
Northern California Kaiser, Division of Research | Oakland, California 94612 |
Massachusetts General Hospital, Harvard Medical School | Boston, Massachusetts 02114 |