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YAZ, Oral Contraceptive Registration in China

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: NCT00819312
Recruitment Status : Completed
First Posted : January 8, 2009
Last Update Posted : January 29, 2013
Sponsor:
Information provided by:
Bayer

Tracking Information
First Submitted Date  ICMJE January 5, 2009
First Posted Date  ICMJE January 8, 2009
Last Update Posted Date January 29, 2013
Study Start Date  ICMJE December 2008
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 7, 2009)
The primary efficacy variable is the number of unintended pregnancies as measured by the Pearl Index (PI) during 13 cycles of treatment. [ Time Frame: 13 cycles (1 cycle= 28 days) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00819312 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 7, 2009)
  • Bleeding pattern indices [ Time Frame: 13 cycles ]
  • Cycle control parameters [ Time Frame: 13 cycles ]
  • Adverse events [ Time Frame: Whole study period ]
  • Laboratory tests [ Time Frame: Whole study period ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE YAZ, Oral Contraceptive Registration in China
Official Title  ICMJE A Multicenter, Open-label, Single-arm Study to Investigate the Efficacy and Safety of the Oral Contraceptive YAZ (20 μg Ethinylestradiol, 3 mg Drospirenone) for 13 Cycles in 670 Healthy Chinese Female Volunteers.
Brief Summary The purpose of this study is to evaluate the effectiveness in terms of prevention of pregnancy and safety of the oral contraceptive YAZ in healthy Chinese women.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Contraception
Intervention  ICMJE Drug: YAZ (SH T00186, BAY86-5300)
20ug ethinylestradiol, 3mg drospirenone, tablet, orally, opd
Study Arms  ICMJE Active Comparator: Arm 1
Intervention: Drug: YAZ (SH T00186, BAY86-5300)
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: December 20, 2010)
675
Original Estimated Enrollment  ICMJE
 (submitted: January 7, 2009)
670
Actual Study Completion Date  ICMJE January 2011
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy women between 18 and 45 requesting oral contraception.
  • Smokers may not exceed 30 years of age.

Exclusion Criteria:

  • The use of steroidal oral contraceptives , or any drug that could alter oral contraception metabolism will be prohibited during the study.
  • Pregnancy, lactation (less than 3 menstrual cycles since delivery, abortion or lactation before start of treatment)
  • Menstrual disorders suspicious of ovarian failure (e.g. oligomenorrhea, amenorrhea, hypomenorrhea
  • Any disease or condition that may worsen under hormonal treatment
  • Other contraceptive methods such as sterilization or IUD/IUS
  • Substantial overweight (BMI > 30 kg/m2).
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 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,   Hong Kong
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00819312
Other Study ID Numbers  ICMJE 91619
311041 ( Other Identifier: company internal )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Therapeutic Area Head, Bayer Healthcare AG
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date January 2013

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