Oxybutynin or venlafaxine for hot flushes in women who cannot or prefer not to use hormone replacement therapy

Phase 4

Active, not recruiting

Conditions: Women experiencing menopausal and peri menopausal hot flushes
Urological and Genital Diseases

Registration Number: ISRCTN32277407

Lead Sponsor: niversity College London

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Ongoing

Sex: Female

Target Recruitment: 960

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

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.