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

Information source: Bayer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Contraception

Intervention: Ethinylestradiol (Drug); drospirenone (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Schering Pharma AG, Germany, Medical Affairs Region Asia/Pacific, Study Director, Affiliation: +65 6511 6194

Summary

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

Clinical Details

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

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

Primary outcome: Cycle control from randomization to cycle 13

Secondary outcome:

Contraceptive reliability

Quality of life

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.

Eligibility

Minimum age: 20 Years. Maximum age: 35 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Healthy Chinese female requesting contraceptives

Exclusion Criteria:

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

Locations and Contacts

Additional Information

Starting date: November 2003
Last updated: May 8, 2007

Page last updated: June 20, 2008

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