Women experiencing menopausal and peri menopausal hot flushes Urological and Genital Diseases
Conditions
Interventions
To compare the relative clinical and cost-effectiveness of extended-release oxybutynin compared to low-dose modified-release venlafaxine in controlling VMS after 3 months of treatment, separately, in
Sponsors
University College London
Eligibility
Sex/Gender
Female
Age
45 Years to 65 Years
Inclusion criteria
Inclusion criteria: Group A (HRT contraindicated) 1. Women for whom HRT is contraindicated, e.g. women with breast cancer treated with adjuvant endocrine therapy. 2. =5 moderate/ severe menopausal hot flushes daily average, collected over a week, prior to randomisation. 3. Written/electronic informed consent. Group B (prefer not to use HRT) 1. Diagnosis of menopause or perimenopause 2. Age > 45 years 3. =5 moderate/ severe menopausal hot flushes daily average, collected over a week, prior to randomisation. 4. Not intending to use HRT within 12 months. 5. Written/electronic informed consent.
Exclusion criteria
Exclusion criteria: Group A (HRT contraindicated) 1. Age >65 years 2. Contraindications to either trial treatment 3. Pregnant or planning on becoming pregnant or breastfeeding 4. Breast Cancer patients with advanced stage cancer 5. Taking other pharmacological treatment for VMS* Group B (prefer not to use HRT) 1. Age >65 years 2. Contraindications to either trial treatment 3. Pregnant or planning on becoming pregnant or breastfeeding 4. Transwomen 5. Women already on HRT or using hormonal treatment for gynaecological conditions or contraception*. *Women already on HRT, or other treatments VMS, or who are using treatment for gynaecological conditions or contraception, who want non-hormonal treatment, are eligible if willing to stop their treatment for a =4-week washout period before entering the pre-randomisation eligibility screening phase. Women using a levonorgestrel-releasing intrauterine system (IUS), will not have to complete a washout or stop this treatment while in the trial, due to minimal systemic circulation of levonorgestrel.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The average Hot Flush (HF) score (frequency x severity) over one week, at week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| All measured at baseline, week 12, and 6 and 12 months and additional stated timepoints: 1. Average HF score (also in weeks 4 and 8) 2. Frequency and severity (individually) of hot flushes/night sweats (also in weeks 4 and 8) 3. Individual domains and total score of MENQOL-I (also at week 4) 4. Hot Flush Related Daily Interference Scale (HFRDIS) (also at week 4) 5. Health related quality of life (EQ-5D-5L) and capability-wellbeing (ICECAP-A) 6. Participant acceptability and satisfaction with treatment (also at week 4) 7. Participant-reported global impression of change on VMS and overall wellbeing 8. Urinary urgency, frequency and incontinence (ICIQ-OAB) 9. Sleep quality (PSQI) 10. Work Productivity and Activity Impairment Questionnaire- general (WPAI) 11. Pregnancy and pregnancy outcomes (participant reported and/or patient records) 12. Common known side-effects of each treatment (participant reported via questionnaires) 13. Change or cessation of treatment, and for breast cancer population, continuation of endocrine therapy (participant reported via questionnaires) 14. Resource Use (participant reported via questionnaires ) | — |
Countries
England, Northern Ireland, Scotland, United Kingdom, Wales
Contacts
Public ContactHugh Jarrett
Outcome results
None listed