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Trial record 24 of 27 for:    DROSPIRENONE AND ETHINYL ESTRADIOL AND bleeding

Yasmin 20 Cycle Control - Yasmin 20 Versus Mercilon in Healthy Female Volunteers

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: NCT00624130
Recruitment Status : Completed
First Posted : February 26, 2008
Last Update Posted : December 31, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date  ICMJE February 18, 2008
First Posted Date  ICMJE February 26, 2008
Last Update Posted Date December 31, 2014
Study Start Date  ICMJE March 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: February 25, 2008)
Cycle control and bleeding pattern [ Time Frame: 7 cycles ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00624130 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 25, 2008)
  • Pearl index [ Time Frame: 7 cycles ]
  • Laboratory tests [ Time Frame: Screening ]
  • Adverse Events [ Time Frame: 7 cycles ]
  • General Physical and gynecological examinations [ Time Frame: Screening ]
  • Vital signs [ Time Frame: Screening, admission ]
  • Body weight [ Time Frame: Screening, admission ]
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 Yasmin 20 Cycle Control - Yasmin 20 Versus Mercilon in Healthy Female Volunteers
Official Title  ICMJE Open, Randomized, Parallel Multi-center Comparison of Cycle Control and Safety of the Oral Contraceptive Yasmin 20 in a 24-day Regimen vs. Mercilon for 7 Cycles in 440 Healthy Female Volunteers
Brief Summary The purpose of this study is to compare bleeding pattern of contraceptive Yasmin 20 to a marketed comparator.
Detailed Description Not Provided
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 20
    Yasmin 20, 24-d regimen vs Mercilon, Tablet p.o. (oral)
  • Drug: Mercilon
    Mercilon, 24-d regimen vs Yasmin 20 , Tablet p.o. (oral)
Study Arms  ICMJE
  • Experimental: Arm 1
    Intervention: Drug: Yasmin 20
  • Active Comparator: Arm 2
    Intervention: Drug: Mercilon
Publications *

*   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 30, 2014)
453
Original Actual Enrollment  ICMJE
 (submitted: February 25, 2008)
440
Actual Study Completion Date  ICMJE June 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy female volunteer aged 18-35,
  • Smokers 18-30

Exclusion Criteria:

  • Contraindications for using hormonal contraceptives
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 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 Austria,   Estonia,   Finland,   Lithuania
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00624130
Other Study ID Numbers  ICMJE 91352
308020
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date December 2014

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