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Trial record 17 of 25 for:    gestodene

Transdermal Contraceptive Patch - Endometrial Effects Study

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: NCT00896571
Recruitment Status : Completed
First Posted : May 11, 2009
Last Update Posted : November 26, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date  ICMJE May 8, 2009
First Posted Date  ICMJE May 11, 2009
Last Update Posted Date November 26, 2014
Study Start Date  ICMJE July 2009
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2009)
Effect on the endometrium at cycle 13 [ Time Frame: 13 treatment cycles (each consisting of 28 days) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00896571 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 6, 2012)
  • Cervical smear [ Time Frame: 13 treatment cycles (each consisting of 28 days) ]
  • Adverse events [ Time Frame: 13 treatment cycles (each consisting of 28 days) ]
  • Cycle control [ Time Frame: 13 treatment cycles (each consisting of 28 days) ]
  • Safety laboratory [ Time Frame: 13 treatment cycles (each consisting of 28 days) ]
  • Occurence of pregnancy [ Time Frame: 13 treatment cycles (each consisting of 28 days) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2009)
  • Treatment compliance [ Time Frame: 13 treatment cycles (each consisting of 28 days) ]
  • Subjective assessment of satisfaction with the treatment [ Time Frame: 13 treatment cycles (each consisting of 28 days) ]
  • Cervical smear [ Time Frame: 13 treatment cycles (each consisting of 28 days) ]
  • Adverse events [ Time Frame: 13 treatment cycles (each consisting of 28 days) ]
  • Cycle control [ Time Frame: 13 treatment cycles (each consisting of 28 days) ]
  • Safety laboratory [ Time Frame: 13 treatment cycles (each consisting of 28 days) ]
  • Occurence of pregnancy [ Time Frame: 13 treatment cycles (each consisting of 28 days) ]
Current Other Pre-specified Outcome Measures
 (submitted: December 6, 2012)
  • Treatment compliance [ Time Frame: 13 treatment cycles (each consisting of 28 days) ]
  • Subjective assessment of satisfaction with the treatment [ Time Frame: 13 treatment cycles (each consisting of 28 days) ]
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Transdermal Contraceptive Patch - Endometrial Effects Study
Official Title  ICMJE Single-center,Open-label, Uncontrolled Study to Investigate the Effects of the Transdermal Contraceptive Patch Containing 0.55 mg Ethinylestradiol and 2.1 mg Gestodene on the Endometrium in a 21-day Regimen for 13 Cycles in 80 Healthy Women
Brief Summary The aim of the present study is to investigate the effects of the transdermal patch on the endometrium in healthy women who require contraception.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Contraception
Intervention  ICMJE Drug: Ethinylestradiol/Gestogene (BAY86-5016)
7-day patch containing 0.55 mg ethinylestradiol (EE) and 2.1 mg gestodene (GSD) in a 21-day regimen
Study Arms  ICMJE Experimental: Arm 1
Intervention: Drug: Ethinylestradiol/Gestogene (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: June 24, 2010)
92
Original Estimated Enrollment  ICMJE
 (submitted: May 8, 2009)
100
Actual Study Completion Date  ICMJE August 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Requiring contraception
  • Normal cervical smear
  • Smokers not older than 30 years
  • History of regular cyclic menstrual periods

Exclusion Criteria:

  • Pregnancy or lactation
  • Obesity (BMI> 30 kg/m2)
  • 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 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 Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00896571
Other Study ID Numbers  ICMJE 14287
2009-010599-45 ( EudraCT Number )
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 November 2014

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