Comparative Efficacy of Low-Dose Estradiol and the SNRI Venlafaxine XR for Treatment of Menopausal Symptoms
The MsFLASH-03 study, Comparative Efficacy of Low-Dose Estradiol and the SNRI Venlafaxine XR
for Treatment of Menopausal Symptoms, is a randomized, double-blind, placebo-controlled,
three 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 oral estradiol, venlafaxine,
or placebo; followed by 14 days of drug taper for those on venlafaxine and 14 days of
progesterone treatment for those on estradiol; followed by 2 weeks with no treatment for all
groups; and a telephone follow-up post-treatment.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Frequency of hot flashes
Measured by self-report diary twice daily for 7 days
8 weeks
No
Andrea Z LaCroix, PhD
Principal Investigator
Fred Hutchinson Cancer Research Center
United States: Federal Government
MsFLASH-03
NCT01418209
November 2011
January 2013
Name | Location |
---|---|
Brigham and Women's Hospital | Boston, Massachusetts 02115 |
Massachusetts General Hospital, Harvard Medical School (HU) | Boston, Massachusetts 02114 |
University of Pennsylvania, UP | Philadelphia, Pennsylvania 19104 |
Group Health Research Institute (GHRI) | Seattle, Washington 98101 |