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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01015677 |
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Date of registration:
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17/11/2009 |
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Primary sponsor: |
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Public title:
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A Study of MK6913 for the Treatment of Hot Flashes in Postmenopausal Women (6913-004)
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Scientific title:
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A Phase IIa, Randomized, Double-Blind, Placebo- and Active-Controlled Study to Examine MK6913 for the Treatment of Vasomotor Symptoms in Postmenopausal Women |
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Date of first enrolment:
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December 2009 |
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Target sample size:
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300 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01015677 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Countries of recruitment
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Australia
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Belgium
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Canada
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France
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New Zealand
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United States
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Contacts
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Name:
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Medical Monitor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Merck |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patient is a woman with at least 50 moderate to very severe hot flash episodes per
week
- Patient is postmenopausal
- Patient is between 45 and 60 years of age if naturally menopausal, or between 35 and
60 if she underwent a bilateral oophorectomy
- Patient is not receiving hormone therapy
- Patient has had both a normal mammogram and a normal Pap test in the past 6 months
- Patient is generally healthy
Exclusion Criteria:
- Patient has a history of cancer, except for certain skin cancers
- Patient has undiagnosed vaginal bleeding or any uterine endometrial disorder
- Patient currently uses tobacco products, or has used them in the last 6 months
- Patient has HIV
Age minimum:
35 Years
Age maximum:
60 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Moderate to Severe Vasomotor Symptoms
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Intervention(s)
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Drug: Comparator: 17beta-estradiol
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Drug: Comparator: MK6913
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Drug: Comparator: placebo
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Drug: MK6913
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Primary Outcome(s)
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Change from baseline in the number of moderate to very severe hot flashes
[Time Frame: Week 4]
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Secondary Outcome(s)
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Change from baseline in FSH (follicle-stimulating hormone) level
[Time Frame: Week 4]
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Change from baseline in hot flash severity score
[Time Frame: Baseline and 4 weeks]
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Secondary ID(s)
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2009_691
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MK6913-004
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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