Dose-Finding Safety and Efficacy Trial in the Treatment of Vasomotor Symptoms (46101)(COMPLETED)
The most direct treatment of a hot flush, maybe by means of5-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 Org 50081 compared to placebo was investigated in women with moderate to severe vasomotor symptoms associated with the menopause.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Four Different Doses of Org 50081 in the Treatment of Moderate to Severe Vasomotor Symptoms Associated With the Menopause|
- To demonstrate superior efficacy of Org 50081 as compared to placebo on the mean change from baseline in average daily frequency and severity [ Time Frame: At weeks 4 and 12 (Total timeframe 12 weeks) ] [ Designated as safety issue: No ]
- Evaluate the effect of four different doses of Org 50081 compared to placebo on the Health Status assessment as measured by the Womens Health Questionaire [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||October 2004|
|Study Completion Date:||January 2006|
|Primary Completion Date:||January 2006 (Final data collection date for primary outcome measure)|
Drug: Org 50081
four different doses (2.25, 4.5, 9.0, and 18 mg)
Encapsulated Org 50081 tablets in Swedish Orange hard gelatin DB-B capsules containing titanium dioxide (E171), iron oxide red (E172). Org 50081 tablets contained the following excipients: sodium starch glycolate,magnesium stearate, and lactose monohydrate.
Encapsulated tablets were administered orally once daily in the evening prior to sleep for 12 weeks
Placebo Comparator: 2
Encapsulated placebo tablets in Swedish Orange hard gelatin DB-B capsules containing gelatin, titanium dioxide (E171), iron oxide red (E172). The placebo tablets contained the following excipients: maize starch, magnesium stearate, and lactose monohydrate. Batchnumbers: BX091 and CX162.