Neurokinin 3 receptor antagonism as a novel treatment for menopausal hot flushes: a phase 2, randomised, double-blind, placebo-controlled trial

Publication date: Available online 3 April 2017 Source:The Lancet Author(s): Julia K Prague, Rachel E Roberts, Alexander N Comninos, Sophie Clarke, Channa N Jayasena, Zachary Nash, Chedie Doyle, Deborah A Papadopoulou, Stephen R Bloom, Pharis Mohideen, Nicholas Panay, Myra S Hunter, Johannes D Veldhuis, Lorraine C Webber, Les Huson, Waljit S Dhillo Background Hot flushes affect 70% of menopausal women and often severely impact physical, psychosocial, sexual, and overall wellbeing. Hormone replacement therapy is effective but is not without risk. Neurokinin B signalling is increased in menopausal women, and has been implicated as an important mediator of hot flushes. Methods This phase 2, randomised, double-blind, placebo-controlled, single-centre, crossover trial assessed the effectiveness of an oral neurokinin 3 receptor antagonist (MLE4901) on menopausal hot flushes. Eligible participants were healthy women aged 40–62 years, having seven or more hot flushes in every 24 h of which some were reported as being severe or bothersome, who had not had a menstrual period for at least 12 months, and who had not been taking any medication shown to improve menopausal flushes in the preceding 8 weeks. Participants received 4 weeks of MLE4901 (40 mg, orally, twice daily) and placebo (orally, twice daily) in random order separated by a 2 week washout period. Randomisation was completed by a central computer, and participants were allocated to treatment number in nume...
Source: The Lancet - Category: Journals (General) Source Type: research