Post-Menopausal Hot Flushes

At MAC Clinical Research we’re currently conducting a trial to test an investigational medication for symptoms in post-menopausal women. Post-menopausal symptoms include hot flushes which are episodes of flushing, sweating, and intense heat sensation. There are few good treatment options currently available. HRT is effective but may have unwelcome side effects. Current non-hormonal options often provide unsatisfactory symptom relief.

The investigational medication being developed, SJX-653 works in a different way from existing treatment options. It is not a hormonal medication. SJX-653 is a substance that can block an activity in your brain that is thought to be involved in causing hot flushes and night sweats. It is expected that this will decrease the number and severity of hot flushes and night sweats experienced.

Eligible patients will receive either trial medication or matching placebo. There will be a 50% chance that you’ll get the trial medication. The trial medication or placebo will be taken orally, once daily for 4 weeks and there will be approximately 7 visits in total to one of our clinics (some optional at home visits, where appropriate).

A full description of the study will be given to you before you decide to take part, both over the phone and during an appointment at the MAC clinic. This will include you receiving the full patient information sheet (PIS). Your GP will also be notified of your participation.

Reimbursement: Up to max £635 (depending on scheduling visits, minimum is £385) plus a maximum travel payment of £35 per visit.

Criteria

* Key Inclusion Criteria:

• Post-menopausal females aged 40 – 65
• Experiencing hot flushes
• BMI 18 – 35

* Key Exclusion Criteria:

• Any uncontrolled or unstable medical condition
• Type 1 diabetics and anyone requiring insulin treatment
• Unwilling to stop use of any hormonal therapy for the duration of the trial

Other eligibility criteria will apply. Please contact MAC for more information.

Any other information
Eligible patients will receive a comprehensive health screen and study participation will be in collaboration with the patient’s treating physician.