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Treatment of Vasomotor Symptoms in Korean Post Menopausal Women
This study has been completed.
Study NCT00651599   Information provided by Bayer
First Received: April 1, 2008   Last Updated: July 14, 2009   History of Changes

April 1, 2008
July 14, 2009
July 2004
 
Hot flush (frequency and severity) [ Time Frame: Daily in pre-treatment and treatment period ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00651599 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
 
Treatment of Vasomotor Symptoms in Korean Post Menopausal Women
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

Study to demonstrate that the therapeutic efficacy of Angeliq® is better than placebo in Korean postmenopausal women with hot flushes and other climacteric symptoms. Safety and tolerability of Angeliq.

 
Phase III
Interventional
Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Vasomotor Symptoms
  • Drug: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)
  • Drug: Placebo
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
72
May 2005
 

Inclusion Criteria:

  • Postmenopausal Korean women suffering from hot flushes

Exclusion Criteria:

  • Standard exclusion criteria for HRT clinical trials had to be obeyed, including current or history of hormone dependent malignant disease, thromboembolic disorders, abnormal cervical smear, undiagnosed vaginal bleeding.
Female
45 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00651599
Therapeutic Area Head, Bayer Schering Pharma AG
91354, 308381
Bayer
 
Study Director: Bayer Study Director Bayer
Bayer
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP