BLUSH
Research type
Research Study
Full title
Oxybutynin Or Venlafaxine For Hot Flushes In Women Who Cannot Or Prefer Not To Use Hormone Replacement Therapy: Randomised Trial And Economic Evaluation
IRAS ID
1006998
Contact name
Jane Daniels
Contact email
Sponsor organisation
University College London
ISRCTN Number
00000000
Clinicaltrials.gov Identifier
00000000
Research summary
Most menopausal women experience vasomotor symptoms (VMS), including hot flushes and night sweats, lasting several years. They can have a significant impact on the lives of affected women. Hot flushes can be particularly severe for women taking endocrine therapies for treatment of breast cancer. Hormone replacement therapy (HRT) is the most effective treatment for hot flushes. However, some women are unable to take HRT because of other health conditions, such as a history of breast cancer. Others may choose not to take HRT because of concerns about the potential harms of HRT. All non-hormonal drugs are less effective than HRT and have side-effects.
The most commonly prescribed non hormonal treatment for menopausal hot flushes is called venlafaxine. There is evidence that oxybutynin, a medicine currently used to treat an overactive bladder, is effective in reducing the frequency of hot flushes and could be more effective than venlafaxine. We want to find out which of venlafaxine or oxybutynin is best for the relief of menopausal hot flushes.
We will recruit 480 participants who are experiencing menopausal VMS symptoms but are unable to take HRT and 480 participants who prefer not to take HRT. Participants will be randomly allocated to either oxybutynin or venlafaxine, and asked to take this treatment for 12 months. Participants will also be asked to keep a diary about their hot flushes and complete questionnaires at various points throughout the trial.REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
23/EM/0138
Date of REC Opinion
11 Sep 2023
REC opinion
Further Information Favourable Opinion