Treatment of Vasomotor Symptoms in Korean Post Menopausal Women - Tabular View

Tracking Information

First Received Date ^ICMJE

April 1, 2008

Last Updated Date

July 14, 2009

Start Date ^ICMJE

July 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Hot flush (frequency and severity) [ Time Frame: Daily in pre-treatment and treatment period ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00651599 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Treatment of Vasomotor Symptoms in Korean Post Menopausal Women

Official Title ^ICMJE

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 better than placebo in Korean postmenopausal women with hot flushes and other climacteric symptoms. Safety and tolerability of Angeliq.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Vasomotor Symptoms

Intervention ^ICMJE

Drug: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)
Drug: Placebo

Study Arms / Comparison Groups

Publications *

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

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

May 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Female

Ages

45 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT ID ^ICMJE

NCT00651599

Responsible Party

Therapeutic Area Head, Bayer Schering Pharma AG

Study ID Numbers ^ICMJE

91354, 308381

Study Sponsor ^ICMJE

Bayer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Bayer Study Director

Bayer

Information Provided By

Bayer

Verification Date

July 2009

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