A Clinical Study on Yasmin® vs. Marvelon® in Chinese Women Requiring Contraception - Tabular View

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

January 13, 2009

Start Date ^ICMJE

November 2003

Primary Completion Date

March 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The primary efficacy variable is the comparison of cycle control from randomisation to cycle 13. This will be based on the number of subjects reporting at least 1 unexpected intracyclic bleeding episode between cycles 2 to 13. [ Time Frame: 13 treatment cycles (1 cycle= 28 days) ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Cycle control from randomization to cycle 13

Change History

Complete list of historical versions of study NCT00185419 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Weight changes [ Time Frame: 13 treatment cycles ] [ Designated as safety issue: No ]
Contraceptive reliability [ Time Frame: 13 treatment cycles ] [ Designated as safety issue: No ]
Effects on skin condition [ Time Frame: 13 treatment cycles ] [ Designated as safety issue: No ]
Changes in MDQ subscale scores [ Time Frame: 13 treatment cycles ] [ Designated as safety issue: No ]
Adverse Events [ Time Frame: the whole study period ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Contraceptive reliability
Quality of life

Descriptive Information

Brief Title ^ICMJE

A Clinical Study on Yasmin® vs. Marvelon® in Chinese Women Requiring Contraception

Official Title ^ICMJE

An Open-Label, Randomised, Parallel-Group Comparison to Investigate the Efficacy of Yasmin® (30 µg Ethinylestradiol, 3mg Drospirenone) and Marvelon® (30 µg Ethinylestradiol, 150 µg Desogestrel) on Cycle Control in Healthy Chinese Women Over 13 Cycles

Brief Summary

The purpose of this study is to evaluate the effectiveness in terms of prevention of pregnancy and safety of the oral contraceptive Yasmin and Marvelon on cycle control in healthy Chinese women

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

Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Contraception

Intervention ^ICMJE

Drug: Yasmin
Drug: Marvelon

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

842

Completion Date

March 2006

Primary Completion Date

March 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Healthy Chinese female requesting contraceptives

Exclusion Criteria:

Vascular, metabolic, hepatic, renal, oncologic and other diseases

Gender

Female

Ages

20 Years to 35 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

China

Administrative Information

NCT ID ^ICMJE

NCT00185419

Responsible Party

Therapeutic Area Head, Bayer Schering Pharma AG

Study ID Numbers ^ICMJE

91330, 308062

Study Sponsor ^ICMJE

Bayer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Bayer Study Director

Bayer

Information Provided By

Bayer

Verification Date

January 2009

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