Study name: BLUSH Status: Set-up
Oxybutynin or venlafaxine for hot flushes in women who cannot or choose not to use hormone replacement therapy: randomised trial and economic evaluation
Contact:
BLUSH@nottingham.ac.uk
Lead Investigator:
Melanie Davies (UCLH)
What is the study about?
Most menopausal women experience vasomotor symptoms (VMS), including hot flushes and night sweats, lasting several years. VMS are more frequent and intense in women taking breast cancer treatment, which can reduce compliance. All alternatives are less effective than HRT and have side effects.
The study is investigating if oxybutynin is more effective and better value for money than venlafaxine at controlling VMS in two groups of women: those who prefer not to use menopausal Hormone Replacement Treatment (HRT), and those with contraindications to HRT.
Who can take part in the study?
Women with menopausal VMS who are either unable to take, or prefer not to take, HRT.
What is being tested in the study?
Oxybutynin
What is this being compared to?
Venlafaxine
What are we trying to find out?
If oxybutynin is more effective and better value for money than venlafaxine at controlling menopausal VMS in the short and long term.
The primary outcome will be a measure of hot flushes (frequency x severity) after 12 weeks of treatment.
How many patients do we need?
480 women who prefer not to use HRT
480 women who cannot take HRT for medical reasons
Funder:
NIHR - HTA