The purpose of this study is to compare the efficacy and safety of Yasmin® and Marvelon® in Chinese women requiring...
Date First Received: September 13, 2005
Last Updated: May 8, 2007
Verified by: Bayer, May 2007
Clinical Trial Phase: Phase 3 | Start Date: November 2003
Overall Status: Completed
Brief Summary
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”
Condition Keyword(s):
Intervention(s):
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
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- Drug: Ethinylestradiol
- Drug: drospirenone
Outcome Measures for this Clinical Trial
Primary Measures
- Cycle control from randomization to cycle 13
Secondary Measures
- Contraceptive reliability
- Quality of life
Criteria for Participation in this Clinical Trial
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
Clinical Trial Sponsor Information
Lead Sponsor: Bayer
Overall Clinical Trial Officials and Contacts
Bayer Schering Pharma AG, Germany, Medical Affairs Region Asia/Pacific Study Director +65 6511 6194
Additional Information
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
Clinical Trials Authorship and Review
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