Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Transdermal Contraceptive Patch - Endometrial Effects Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00896571
First received: May 8, 2009
Last updated: December 11, 2013
Last verified: December 2013

May 8, 2009
December 11, 2013
July 2009
May 2011   (final data collection date for primary outcome measure)
Effect on the endometrium at cycle 13 [ Time Frame: 13 treatment cycles (each consisting of 28 days) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00896571 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Cycle control [ Time Frame: 13 treatment cycles (each consisting of 28 days) ] [ Designated as safety issue: No ]
  • Safety laboratory [ Time Frame: 13 treatment cycles (each consisting of 28 days) ] [ Designated as safety issue: Yes ]
  • Occurence of pregnancy [ Time Frame: 13 treatment cycles (each consisting of 28 days) ] [ Designated as safety issue: Yes ]
  • 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 ]
  • Cycle control [ Time Frame: 13 treatment cycles (each consisting of 28 days) ] [ Designated as safety issue: No ]
  • Safety laboratory [ Time Frame: 13 treatment cycles (each consisting of 28 days) ] [ Designated as safety issue: Yes ]
  • Occurence of pregnancy [ Time Frame: 13 treatment cycles (each consisting of 28 days) ] [ Designated as safety issue: Yes ]
  • 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 ]
Not Provided
 
Transdermal Contraceptive Patch - Endometrial Effects Study
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

The aim of the present study is to investigate the effects of the transdermal patch on the endometrium in healthy women who require contraception.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Contraception
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
Experimental: Arm 1
Intervention: Drug: Ethinylestradiol/Gestogene (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
92
August 2011
May 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
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00896571
14287, 2009-010599-45
No
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
December 2013

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