Oxybutynin or venlafaxine for hot flushes in women who cannot or prefer not to use hormone replacement therapy: randomised trial and economic evaluation

niversity College London0 个研究点目标入组 960 人开始时间: 2023年11月1日最近更新: 2024年7月15日

适应症

试验速览

暂无简介。

•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.

•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.

发起方