Status

Paused due to a shortage of oxybutynin in pharmacies

 

Lead Investigator

Dr Melanie Davies

Consultant Obstetrician and Gynaecologist

University College London Hospital

 

 

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

National Institute for Health and Care Research - Health Technology Assessment (NIHR - HTA)