Treatment of Hot Flushes in Asian Women With Ultra-low Dose Estradiol Patch
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ClinicalTrials.gov Identifier: NCT00185237 |
Recruitment Status :
Completed
First Posted : September 16, 2005
Last Update Posted : December 23, 2014
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Sponsor:
Bayer
Information provided by (Responsible Party):
Bayer
Tracking Information | ||||
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First Submitted Date ICMJE | September 9, 2005 | |||
First Posted Date ICMJE | September 16, 2005 | |||
Last Update Posted Date | December 23, 2014 | |||
Study Start Date ICMJE | July 2005 | |||
Actual Primary Completion Date | November 2006 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Relative change in frequency of hot flushes [ Time Frame: 12 weeks ] | |||
Original Primary Outcome Measures ICMJE |
Relative change from baseline to Week 12 in frequency of hot flushes | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Treatment of Hot Flushes in Asian Women With Ultra-low Dose Estradiol Patch | |||
Official Title ICMJE | A Multicenter, Double-blind, Randomized, Placebo Controlled Study on the Effect of Ultra-low Dose Transdermal Estradiol (Menostar®) on the Incidence and Severity of Hot Flushes, Other Menopausal Symptoms and on Well-being in Postmenopausal Asian Women Over 12 Weeks. | |||
Brief Summary | 150 postmenopausal Asian women with vasomotor symptoms, after fulfilling the inclusion and exclusion criteria will be enrolled in the study. The women will be randomly assigned to one of two treatment groups (Menostar® or placebo), after which they will be asked to use a patch once a week for 12 weeks. | |||
Detailed Description | The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Hot Flashes | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
165 | |||
Original Enrollment ICMJE | Not Provided | |||
Actual Study Completion Date ICMJE | November 2006 | |||
Actual Primary Completion Date | November 2006 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 45 Years to 65 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Not Provided | |||
Removed Location Countries | Hong Kong, Malaysia, Philippines, Singapore, Thailand | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00185237 | |||
Other Study ID Numbers ICMJE | 91441 309120 |
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Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Bayer | |||
Study Sponsor ICMJE | Bayer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Bayer | |||
Verification Date | December 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |