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Sponsored by: |
Organon |
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Information provided by: | Organon |
ClinicalTrials.gov Identifier: | NCT00560833 |
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.
Condition | Intervention | Phase |
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Menopause Vasomotor Symptoms |
Drug: Org 50081 Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Enrollment: | 942 |
Study Start Date: | October 2004 |
Study Completion Date: | January 2006 |
Primary Completion Date: | January 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Org 50081
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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 |
2: Placebo Comparator
placebo
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Drug: Placebo
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.
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Ages Eligible for Study: | 40 Years to 65 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | NV Organon, part of Schering-Plough Corporation ( Study Director ) |
Study ID Numbers: | 46101 |
Study First Received: | November 16, 2007 |
Last Updated: | August 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00560833 |
Health Authority: | United States: Food and Drug Administration; Belgium: Federal Agency for Medicinal Products and Health Products; Brazil: Ministry of Health; Canada: Health Canada; Czech Republic: State Institute for Drug Control; Denmark: Danish Medicines Agency; Hungary: National Institute of Pharmacy; Netherlands: Medicines Evaluation Board (MEB); Norway: Norwegian Medicines Agency; Slovakia: State Institute for Drug Control; Spain: Spanish Agency of Medicines; Switzerland: Swissmedic; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Signs and Symptoms Titanium dioxide Iron Menopause |