Official Title: “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”

The purpose of this study is to compare the efficacy and safety of Yasmin® and Marvelon® in Chinese women requiring contraception

Study Type: Interventional

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

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.

Intervention(s) in this Clinical Trial

• Drug: Ethinylestradiol
• Drug: drospirenone

Primary Measures

• Cycle control from randomization to cycle 13

Secondary Measures

• Contraceptive reliability
• Quality of life

Inclusion Criteria:

• Healthy Chinese female requesting contraceptives

Exclusion Criteria:

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: 35 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Bayer

Overall Clinical Trial Officials and Contacts

Bayer Schering Pharma AG, Germany, Medical Affairs Region Asia/Pacific Study Director +65 6511 6194  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00185419

Study ID Number: 308062

ClinicalTrials.gov Identifier: NCT00185419

Health Authority: China: State Food and Drug Administration