Placebo-controlled, double-blinded, cross-over clinical trial of a new investigational product
Double-blinded, placebo-controlled, 2-way crossover study in 30 menopausal women with untreated hot flushes treated with a neurokinin 3 receptor (NK3R) antagonist Aims: To investigate whether an NK3R antagonist can reduce menopausal flushing Treatment: 4 weeks administration of active drug and placebo in random order
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
37
Neurokinin 3 receptor antagonist
Placebo
NIHR/Wellcome Trust Imperial CRF
London, United Kingdom
Total Number of Hot Flushes During the Final Week of Each 4 Weeks Treatment Period
To ensure accurate records, participants recorded their flushes in real time using either a tally chart on a piece of paper (n=34) or an application on their smartphone such as Tally Counter (Pixel Research Labs, Minneapolis-Saint Paul, MN, USA; n=3), and then collated their total number of flushes twice daily on waking to record previous overnight symptoms and before bed to record daytime symptoms.
Time frame: Final week of each 4 week treatment period
Hot Flush Severity
Score on a scale - HF severity (rated as 1-nil, 2-mild, 3-moderate, 4-severe, as per Joffe 2014) recorded twice daily (day/night as described above for HF frequency). Scores are summed.
Time frame: Twice daily, morning and night for 14 weeks
Hot Flush Bother
Score on a scale - HF bother (rated as 1-none, 2-a little, 3-moderate, 4-a lot, as per Joffe 2014) will be recorded twice daily (day/night as described above for HF frequency). The data will be analysed as detailed above for the HF frequency. Scores are summed.
Time frame: twice daily (day/night) for 14 weeks
Hot Flush Interference
Score on a scale Menopause Specific Quality of Life (MENQOL) questionnaire 0=not bothered at all - 6=extremely bothered. 4 domains, mean calculated for set of questions in each domain. Overall score is a mean of the means. Highr scor = higher interference.
Time frame: Daily at bedtime for 14 weeks
Skin Conductance Monitor Data.
Mean number of flushes detected during the 48 hours by the skin conductance monitoring will be compared each week when the patients receive AZD4901 versus placebo
Time frame: Once per week for 48 hours over 14 weeks
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