Conditions: Menopausal Flushing
Keywords: Menopausal flushing
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 37
Healthy volunteers: yes

Brief summary:
Placebo-controlled, double-blinded, cross-over clinical trial of a new investigational product

Detailed description:
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

Arms:
arm 1: Baseline period - 2 weeks NK3R antagonist - AZD4901 - 40mg bd - 4 weeks Washout period - 2 weeks Matched placebo orally bd - 2 weeks Monitoring period - 2 weeks arm 2: Baseline period - 2 weeks Matched placebo orally bd - 2 weeks Washout period - 2 weeks NK3R antagonist - AZD4901 - 40mg bd - 4 weeks Monitoring period - 2 weeks

Interventions: intervention 1: NK3R antagonist - AZD4901 intervention 2: Placebo
Intervention descriptions: intervention 1: Neurokinin 3 receptor antagonist intervention 2: Placebo

Protocol document: