Effect of SJX-653 on Moderate to Severe Hot Flushes due to Menopause
Research type
Research Study
Full title
A phase 2, prospective, randomized, double-blind, placebo-controlled clinical study to assess the efficacy, safety, tolerability, and pharmacokinetics of SJX-653 in postmenopausal women with moderate to severe vasomotor symptoms
IRAS ID
270898
Contact name
Ruth Thieroff-Ekerdt
Contact email
Sponsor organisation
Sojournix, Inc.
Eudract number
2019-002281-12
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
This clinical study is for an experimental medicine called SJX-653. SJX-653 is being investigated as a once daily non-hormonal therapy for treating hot flushes and night sweats due to menopause.
Menopause is a transition when a woman stops having periods and is no longer able to get pregnant naturally and is linked to a change in the balance of the body’s hormones. Most women experience the menopausal symptoms of hot flushes and night sweats and these can last for many years. For some women the symptoms are severe enough to interfere with daily activities and sleep.
In this study SJX-653 will be studied in 130 women between ages of 40 and 65 years, who have gone through menopause (called post-menopausal) and who suffer from hot flushes and night sweats, to determine if it can reduce the number of hot flushes and night sweats, and how bad they feel. The study will also examine how well SJX-653 is tolerated and how the body absorbs and breaks down SJX-653, by measuring the amount of SJX-653 in the blood at specific times after the drug is given (this is called pharmacokinetics).
Participants will receive one of two doses of SJX-653 or placebo by mouth once daily for 12 weeks. Neither the participants nor the study doctor will know which product have been given (SJX-653 or placebo).The study will consist of approximately 11 study visits incorporating a screening phase of up to 6 weeks, a study treatment phase of 12 weeks, and follow-up phase of 4 weeks. The expected duration of the study is approximately 22 weeks.
The study is being carried out at approximately 30 study sites in Europe.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
19/YH/0351
Date of REC Opinion
3 Dec 2019
REC opinion
Further Information Favourable Opinion