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Sponsored by: |
Organon |
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Information provided by: | Organon |
ClinicalTrials.gov Identifier: | NCT00535288 |
To investigate efficacy and safety of 4 doses of Org 50081, compared to placebo, in the treatment of moderate to severe hot flushes associated with the menopause. Co-primary efficacy endpoints are the frequency and severity of hot flushes after 4 and 12 weeks as compared to Baseline.
Condition | Intervention | Phase |
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Postmenopausal Symptoms Menopause Vasomotor Symptoms |
Drug: Org 50081 Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), 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: | 946 |
Study Start Date: | September 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 for blinding purposes. 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 for blinding purposes. Encapsulated tablets were administered orally once daily in the evening prior to sleep for 12 weeks.
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The most direct treatment of 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 Org 50081 compared to placebo was investigated in women with moderate to severe vasomotor symptoms associated with the menopause.
The primary objective of this trial was to demonstrate superior efficacy in at least one of the four doses of Org 50081 as compared to placebo on the four following co-primary endpoints:
The number and severity of hot flushes was recorded by means of electronic diary by the subjects.
Ages Eligible for Study: | 40 Years to 65 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Postmenopausal women, defined as:
Exclusion Criteria:
Any of the following treatments within the last 4 weeks prior to screening (and up to and including randomization):
Responsible Party: | NV Organon, part of Schering-Plough Corporation ( Study Director ) |
Study ID Numbers: | 177001, White Moonstone |
Study First Received: | September 24, 2007 |
Last Updated: | August 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00535288 History of Changes |
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 Menopause |