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| Descriptive Information Fields | |||||
| Brief Title † | Treatment of Vasomotor Symptoms in Korean Post Menopausal Women | ||||
| Official Title † | A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Tolerability of Angeliq(drospirenon2mg and Estradiol 1mg) in Postmenopausal Korean Women With Vasomotor Symptoms Over 3, 28 Day Treatment Cycle | ||||
| Brief Summary | Study to demonstrate that the therapeutic efficacy of Angeliq® is superior to placebo in Korean postmenopausal women with hot flushes and other climacteric symptoms. Safety and tolerability of Angeliq®. |
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| Detailed Description | |||||
| Study Phase | Phase III | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study | ||||
| Primary Outcome Measure † | Hot flush (frequency and severity) [ Time Frame: Daily in pre-treatment and treatment period ] [ Designated as safety issue: No ] | ||||
| Secondary Outcome Measure † | Menopausal symptoms [ Time Frame: Baseline and after 4 weeks, 8, 12 and 16 weeks of treatment ] [ Designated as safety issue: No ] Urogenital symptoms [ Time Frame: Baseline and after 4 weeks, 8, 12 and 16 weeks of treatment ] [ Designated as safety issue: No ] Assessment of bleeding [ Time Frame: daily in pre-treatment and treatment period ] [ Designated as safety issue: No ] |
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| Condition † | Vasomotor Symptoms | ||||
| Intervention † | Drug: Angeliq® (2 mg drospirenone and 1 mg estradiol) Drug: Placebo |
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| MEDLINE PMIDs | |||||
| Links | Click here to find results for studies related to marketed products ![]() Click here and search for drug information provided by the FDA  ![]() Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product  ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | 72 | ||||
| Start Date † | July 2004 | ||||
| Completion Date | May 2005 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 45 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | Korea, Republic of | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00651599 | ||||
| Organization ID | 91354 | ||||
| Secondary IDs †† | 308381 | ||||
| Study Sponsor † | Bayer | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | Bayer | ||||
| Verification Date | April 2008 | ||||
| First Received Date † | April 1, 2008 | ||||
| Last Updated Date | April 2, 2008 | ||||