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 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

Study Type: Interventional

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

Study Primary Completion Date: March 2006

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: Yasmin
  • 30 µg ethinylestradiol, 3mg drospirenone
• Drug: Marvelon
  • 30 µg ethinylestradiol, 150 µg desogestrel

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Arm 1
• Active Comparator: Arm 2

Primary Measures

• 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)
    Safety Issue?: No

Secondary Measures

• Weight changes
  • Time Frame: 13 treatment cycles
    Safety Issue?: No
• Contraceptive reliability
  • Time Frame: 13 treatment cycles
    Safety Issue?: No
• Effects on skin condition
  • Time Frame: 13 treatment cycles
    Safety Issue?: No
• Changes in MDQ subscale scores
  • Time Frame: 13 treatment cycles
    Safety Issue?: No
• Adverse Events
  • Time Frame: the whole study period
    Safety Issue?: Yes

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 Study Director Study Director Bayer  

Information obtained from ClinicalTrials.gov on July 02, 2009

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

Study ID Number: 91330

ClinicalTrials.gov Identifier: NCT00185419

Health Authority: China: State Food and Drug Administration

Click here and search for drug information provided by the FDA

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product

Click here to find results for studies related to marketed products