Safety/Efficacy Study of Drospirenone/Estradiol to Treat Postmenopausal Chinese Women With Vasomotor Symptoms. - Tabular View

Tracking Information

First Received Date ^ICMJE

July 25, 2006

Last Updated Date

October 27, 2008

Start Date ^ICMJE

May 2006

Primary Completion Date

October 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Frequency of hot flushes [ Time Frame: From baseline to week 16 ] [ Designated as safety issue: No ]
Change in intensity of hot flushes [ Time Frame: From baseline to week 16 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Frequency of hot flushes from base to treatment (week 3 to 16).
Change in intensity of hot flushes from baseline to week 16.

Change History

Complete list of historical versions of study NCT00356447 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change in other climacteric symptoms [ Time Frame: From baseline to week 16 ] [ Designated as safety issue: No ]
Vaginal Bleeding pattern [ Time Frame: From baseline to week 16 ] [ Designated as safety issue: Yes ]
Global clinical impression [ Time Frame: From baseline to week 16 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Change in other climacteric symptoms
Bleeding pattern
Global clinical impression

Descriptive Information

Brief Title ^ICMJE

Safety/Efficacy Study of Drospirenone/Estradiol to Treat Postmenopausal Chinese Women With Vasomotor Symptoms.

Official Title ^ICMJE

A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Tolerability of Angeliq® (Drospirenone 2mg and Estradiol 1mg) in Postmenopausal Chinese Women With Vasomotor Symptoms Over Four 28-Day Treatment Cycles.

Brief Summary

The study evaluates in Chinese post-menopausal women the combination of drospirenone 2 mg and estradiol 1 mg for the treatment of climacteric symptoms, such as hot flushes (vasomotor symptoms) and uro-genital complaints.

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 Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Vasomotor Symptoms

Intervention ^ICMJE

Drug: Angeliq
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

249

Completion Date

October 2007

Primary Completion Date

October 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Chinese postmenopausal women with moderate to severe vasomotor symptoms

Exclusion Criteria:

History of steroid hormone dependent malignant disease
Known or suspected malignant or premalignant disease
Current or history of severe heart, liver, renal, psychiatric disease
Hyperlipemia

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

China

Administrative Information

NCT ID ^ICMJE

NCT00356447

Responsible Party

Therapeutic Area Head, Bayer Schering Pharma AG

Study ID Numbers ^ICMJE

91442, 309341

Study Sponsor ^ICMJE

Bayer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Bayer Study Director

Bayer

Information Provided By

Bayer

Verification Date

October 2008

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