Conditions: Menopause Vasomotor Symptoms
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 943
Healthy volunteers: no

Brief summary:
The most direct treatment of vasomotor symptions (hot flushes) may be by means of 5-HT2A receptor antagonist. Mirtazapine is a potent blocker of 5-HT2A receptors and was found to be effective in reducing the number and intensity of hot flushes in preliminary trials. Also several Selective Serotonin Reuptake Inhibitors (SSRIs) and other similar compounds have been investigated to manage hot flushes, confirming the role of the serotonergic system. In the present trial, the efficacy and safety of four different doses of esmirtazapine compared to placebo was investigated in women with moderate to severe vasomotor symptoms associated with the menopause. The primary study hypothesis was that esmirtazapine would show superior efficacy to placebo.

Detailed description:

Arms:
arm 1: Participants receive placebo, encapsulated tablets, orally (PO), once daily (QD) for up to 12 weeks arm 2: Participants receive esmirtazapine 2.25 mg, encapsulated tablets, PO, QD for up to 12 weeks arm 3: Participants receive esmirtazapine 4.5 mg, encapsulated tablets, PO, QD for up to 12 weeks arm 4: Participants receive esmirtazapine 9 mg, encapsulated tablets, PO, QD for up to 12 weeks arm 5: Participants receive esmirtazapine 18 mg, encapsulated tablets, PO, QD for up to 12 weeks

Interventions: intervention 1: esmirtazapine intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: