What is the study about?
Hot flushes affect 70% of menopausal women, with up to 20% of these women describing them as ‘intolerable’. Furthermore hot flushes can last up to 20 years, therefore having a significant and long-lasting effect on quality of life. Hormone Replacement Therapy (HRT) is the mainstay of treatment but confers an increased risk of breast cancer, stroke and thromboembolism. Therefore current guidelines recommend a limited duration of therapy and in several women HRT cannot be prescribed. Some other medications are available to prescribe but these are less effective than HRT. This highlights an unmet need to develop non-hormonal alternative treatments for menopausal flushing.
Neurokinin B (NKB) is a naturally occurring hormone found in healthy people, which helps to regulate the levels of sex hormones (reproductive hormones) in humans. Recent studies in humans show that NKB signalling also controls menopausal hot flushes. We therefore think that blocking the NK3 receptor (the primary receptor for NKB) could be a new treatment approach for menopausal hot flushes.
What does the study involve?
Participants will attend our clinical research facility on a weekly basis for 14 weeks (these visits should typically last less than 45 minutes) at either Hammersmith or Charing Cross hospitals.
The 14 week study period is divided into 5 parts:
1) two week monitoring period (you will not be receiving any study treatment)
2) four week treatment period (you will take tablets of the NKB blocking drug or placebo – dose 40mg twice daily (two tablets twice daily))
3) two week monitoring period (you will not be receiving any study treatment)
4) four week treatment period (you will take tablets of the NKB blocking drug or placebo – dose 40mg twice daily (two tablets twice daily))
5) two week monitoring period (you will not be receiving any study treatment)
The study visits normally need to be scheduled during weekdays, but it may be possible to arrange a weekend visit during exceptional circumstances.
The tablets are taken orally.
At each study visit blood samples will be taken from a vein in the arm (up to 20mls (4 teaspoons of blood) will be taken each time). Throughout the study, participants will be asked to complete standard questionnaires about their symptoms on a twice daily basis (morning and evening) at home (should take a maximum of 10-15 minutes/day), and wear a small monitor on their chest for the first 48 hours of each week (this can be easily removed when washing).
We have full ethical approval (REC ref: 15/LO/1481), and the drug has safely been given to many healthy volunteers previously.
Expenses will be paid
Who are we looking for?
Peri- or menopausal women aged 40-62 years old having regular hot flushes/night sweats
For further information: Please email Dr Julia Prague at firstname.lastname@example.orgNK3R Study