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Trial record 4 of 25 for:    gestodene

Study Investigating the Efficacy and Safety of a Contraceptive Patch for 13 Cycles

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: NCT00910637
Recruitment Status : Completed
First Posted : June 1, 2009
Last Update Posted : February 8, 2013
Sponsor:
Information provided by:
Bayer

Tracking Information
First Submitted Date  ICMJE May 29, 2009
First Posted Date  ICMJE June 1, 2009
Last Update Posted Date February 8, 2013
Study Start Date  ICMJE May 2009
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 29, 2009)
Occurrence of pregnancy (yes/no) while on treatment [ Time Frame: 13 treatment cycles each consisting of 28 days and follow-up period of 14 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00910637 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 29, 2009)
  • Vital signs [ Time Frame: 13 treatment cycles each consisting of 28 days ]
  • Physical and gynecological examinations [ Time Frame: 13 treatment cycles each consisting of 28 days ]
  • Laboratory assessments [ Time Frame: 13 treatment cycles each consisting of 28 days ]
  • Adverse events (AE monitoring) [ Time Frame: 13 treatment cycles each consisting of 28 days ]
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 Study Investigating the Efficacy and Safety of a Contraceptive Patch for 13 Cycles
Official Title  ICMJE Multicenter, Open-label, Uncontrolled Study to Investigate the Efficacy and Safety of the Transdermal Contraceptive Patch Containing 0.55 mg Ethinyl Estradiol and 2.1 mg Gestodene in a 21-day Regimen for 13 Cycles in 1650 Healthy Female Subjects
Brief Summary This study is examining a birth control patch for 13 cycles (1 year).
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: Gestodene/EE Patch (BAY86-5016)
55 mg ethinyl estradiol & 2.1 mg gestodene, 21 days for 13 cycles
Study Arms  ICMJE Experimental: Arm 1
Intervention: Drug: Gestodene/EE Patch (BAY86-5016)
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: February 13, 2011)
1502
Original Estimated Enrollment  ICMJE
 (submitted: May 29, 2009)
1650
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Requiring contraception
  • Normal cervical smear
  • Maximum age for smokers is 35
  • History of regular cyclic menstrual periods

Exclusion Criteria:

  • Pregnancy or lactation
  • Significant skin reaction to transdermal preparations or sensitivity to surgical / medical tape
  • Any disease that may worsen under hormonal treatment (cardiovascular, liver, metabolic)
  • Use of other contraceptive methods than study medication
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00910637
Other Study ID Numbers  ICMJE 91555
310802 ( 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 Pharmaceuticals Inc.
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date February 2013

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