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

Phase 3

Completed

• Conditions: Contraception
• Interventions: Drug: Marvelon; Drug: Yasmin

• Registration Number: NCT00185419
• Lead Sponsor: Bayer

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 Timeline

• Study Start: 2003-11
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-16
• Primary Completion: 2006-03
• Study Completion: 2006-03
• Status Verified: 2009-01
• Last Update Submitted: 2009-01-13
• Last Update Posted: 2009-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 842

Inclusion Criteria

• Healthy Chinese female requesting contraceptives

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2	Marvelon	-
Arm 1	Yasmin	-

Primary Outcome Measures

Name	Time	Method
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.	13 treatment cycles (1 cycle= 28 days)

Secondary Outcome Measures

Name	Time	Method
Weight changes	13 treatment cycles
Contraceptive reliability	13 treatment cycles
Effects on skin condition	13 treatment cycles
Changes in MDQ subscale scores	13 treatment cycles
Adverse Events	the whole study period