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EU/LA Pearl Index Study - Transdermal Contraceptive Patch

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00914693
First received: May 5, 2009
Last updated: October 9, 2011
Last verified: October 2011
History of Changes

May 5, 2009
October 9, 2011
April 2009
September 2011   (final data collection date for primary outcome measure)
Occurrence of pregnancy [ Time Frame: 13 treatment cycles each consisting of 28 days and follow-up period of 14 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00914693 on ClinicalTrials.gov Archive Site
  • Treatment compliance [ Time Frame: 13 treatment cycles each consisting of 28 days ] [ Designated as safety issue: No ]
  • Subjective assessment of satisfaction with the treatment [ Time Frame: 13 treatment cycles each consisting of 28 days ] [ Designated as safety issue: No ]
  • Cervical smear [ Time Frame: 13 treatment cycles each consisting of 28 days ] [ Designated as safety issue: Yes ]
  • Adverse events [ Time Frame: 13 treatment cycles each consisting of 28 days ] [ Designated as safety issue: Yes ]
  • Bleeding pattern and cycle control [ Time Frame: 13 treatment cycles each consisting of 28 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
EU/LA Pearl Index Study - Transdermal Contraceptive Patch
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 (Material no. 80876395) in a 21-day Regimen for 13 Cycles in 1650 Healthy Female Subjects

The aim of the present study is to prove efficacy and safety of a new contraceptive patch.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Contraception
Drug: Ethinylestradiol/Gestodene (BAY86-5016)
7-day patch containing 0.55 mg ethinylestradiol (EE) and 2.1 mg gestodene (GSD) in a 21-day regimen
Experimental: Arm 1
Intervention: Drug: Ethinylestradiol/Gestodene (BAY86-5016)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1694
September 2011
September 2011   (final data collection date for primary outcome measure)

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
Female
18 Years to 35 Years
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Australia,   Chile,   France,   Germany,   Italy,   Mexico,   Spain
 
NCT00914693
91554, EudraCT:2008-004214-27, 310801
No
Therapeutic Area Head, Bayer Healthcare AG
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
October 2011

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