NT-814 in menopausal females with vasomotor symptoms (SWITCH-1 study)
Research type
Research Study
Full title
A Double-Blind, Randomised, Placebo Controlled, Adaptive Design Study of the Efficacy, Safety and Pharmacokinetics of NT-814 in Female Subjects with Moderate to Severe Vasomotor Symptoms Associated with the Menopause.
IRAS ID
253130
Contact name
Nick Panay
Contact email
Sponsor organisation
NeRRe Therapeutics Ltd.
Eudract number
2018-002763-26
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
129492, IND no.
Duration of Study in the UK
0 years, 11 months, 10 days
Research summary
This phase 2b trial is investigating the safety and effectiveness (and pharmacokinetics) of an investigational medicine called NT-814, as a treatment for post-menopausal symptoms.
Many women will experience adverse symptoms related to the menopause, particularly hot flushes, sleep disturbances and adverse mood effects which have a negative impact on women's daily activities and quality of life. Current treatments are limited and include hormone replacement therapy, which is effective in many women, but can be associated with some unwelcome side effects. It is hoped that NT-814, a non-hormonal treatment, may provide rapid and long-lasting control of hot flushes and an improved general quality-of-life.
The study is being conducted across approximately 25 sites in the UK, Canada and the USA, and will enrol women, aged 40 to 65 years old, who are suffering from post-menopausal hot flushes.
Participants will be in the study for approximately 19 weeks during which there will be 8 visits to the clinic. The treatment is 4 capsules taken once-daily for 14 weeks. We are testing four different doses of NT-814; 40, 80, 120, and 160 mg. Participants will receive either one of the NT-814 doses or placebo for most of the study duration. All participants will receive placebo at some time during the study.
To assess the effectiveness of NT-814, participants will record details of their hot flushes in a diary. A paper diary will be completed for 1 week at the beginning of the study, and those participants eligible to continue will then complete an electronic diary (like a mobile phone) twice daily for the remainder of the study. During clinic visits, participants will undergo procedures such as physical examinations, vital signs, and ECGs (electrocardiograms). Participants will also complete questionnaires about their symptoms and quality of life, and blood and urine samples will be taken.REC name
South Central - Hampshire B Research Ethics Committee
REC reference
18/SC/0639
Date of REC Opinion
17 Jan 2019
REC opinion
Further Information Favourable Opinion