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Trial record 11 of 27 for:    DROSPIRENONE AND ETHINYL ESTRADIOL AND bleeding

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00185419
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : January 14, 2009
Sponsor:
Information provided by:
Bayer

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 16, 2005
Last Update Posted Date January 14, 2009
Study Start Date  ICMJE November 2003
Actual Primary Completion Date March 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 13, 2009)
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) ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
Cycle control from randomization to cycle 13
Change History Complete list of historical versions of study NCT00185419 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 13, 2009)
  • Weight changes [ Time Frame: 13 treatment cycles ]
  • Contraceptive reliability [ Time Frame: 13 treatment cycles ]
  • Effects on skin condition [ Time Frame: 13 treatment cycles ]
  • Changes in MDQ subscale scores [ Time Frame: 13 treatment cycles ]
  • Adverse Events [ Time Frame: the whole study period ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
  • Contraceptive reliability
  • Quality of life
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Clinical Study on Yasmin® vs. Marvelon® in Chinese Women Requiring Contraception
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Contraception
Intervention  ICMJE
  • Drug: Yasmin
    30 µg ethinylestradiol, 3mg drospirenone
  • Drug: Marvelon
    30 µg ethinylestradiol, 150 µg desogestrel
Study Arms  ICMJE
  • Active Comparator: Arm 1
    Intervention: Drug: Yasmin
  • Active Comparator: Arm 2
    Intervention: Drug: Marvelon
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 13, 2009)
842
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE March 2006
Actual Primary Completion Date March 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy Chinese female requesting contraceptives

Exclusion Criteria:

  • Vascular, metabolic, hepatic, renal, oncologic and other diseases
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00185419
Other Study ID Numbers  ICMJE 91330
308062
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Therapeutic Area Head, Bayer Schering Pharma AG
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP