Dose-Finding Safety and Efficacy Trial of Org50081 (Esmirtazapine) in the Treatment of Vasomotor Symptoms (46101/P06459/MK-8265-012)
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.
Timeline
- Start
- 2004-10-15
- Primary completion
- 2006-01-15
- Completion
- 2006-01-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Esmirtazapine | Small molecule | 2.25 mg | Oral |
| Subject | Esmirtazapine | Small molecule | 4.5 mg | Oral |
| Subject | Esmirtazapine | Small molecule | 9 mg | Oral |
| Subject | Esmirtazapine | Small molecule | 18 mg | Oral |
Indications
No indication recorded.