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

Bayer0 sites842 target enrollmentNovember 2003

ConditionsContraception

InterventionsYasmin Marvelon

DrugsYasmin Marvelon

Overview

Phase: Phase 3
Intervention: Yasmin
Conditions: Contraception
Sponsor: Bayer
Enrollment: 842
Primary Endpoint: 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.
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2003

End Date

March 2006

Last Updated

17 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Bayer

Eligibility Criteria

Inclusion Criteria

•Healthy Chinese female requesting contraceptives

Exclusion Criteria

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

Arms & Interventions

Arm 1

Intervention: Yasmin

Arm 2

Intervention: Marvelon

Outcomes

Primary Outcomes

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)