DAYLIGHT
Research type
Research Study
Full title
A Phase 3b, Randomized, Double-blind, Placebo-controlled, 24-week Study to Assess the Efficacy and Safety of Fezolinetant in Menopausal Women Suffering from Moderate to Severe Vasomotor Symptoms (Hot Flashes) and Considered Unsuitable for Hormone Replacement Therapy.
IRAS ID
1004019
Contact name
Jena Giese-Pagac
Contact email
Sponsor organisation
Astellas Pharma Global Development, Inc.
Eudract number
2021-001685-38
Research summary
This is a randomised, double blind, placebo controlled, phase 3b clinical study to investigate the safety and efficacy of Fezolinetant when used by menopausal women suffering from moderate to severe Vasomotor Symptoms (Hot Flashes) who are considered unsuitable for Hormone Replacement Therapy (HRT).
This study aims to recruit women with confirmed vasomotor symptoms associated with menopause, between the ages of 40 and 65 (inclusive), seeking treatment for their symptoms.
Participants will be recruited from approximately 100 centres globally.
Participants of the study will undergo up to a 3 week screening period to determine the severity of their hot flushes which will allow the study team to compare the change to their symptoms following the beginning of the study. This will be followed by a number of clinical tests to ensure they meet the physical health requirements for participation. The treatment phase will be 24 weeks long and involve a total of 10 visits to the study site. Participants of the study will self-report on the changes in their symptoms as well as other general health and lifestyle factors.
A number of clinical examinations will also be performed before, during and in the follow up phase of the study to monitor the long term safety of fezolinetant on the physical health of the participants. The study will be placebo controlled, where 50% of participants will not receive Fezolinetant and will act as the control group. 50% of the population will receive a 45mg dose of Fezolinetant. Safety of Fezolinetant will be determined on the basis of adverse events occurring over the course of the study period.
REC name
London - Westminster Research Ethics Committee
REC reference
21/LO/0681
Date of REC Opinion
3 Nov 2021
REC opinion
Further Information Favourable Opinion