Transdermal Contraceptive Patch - Endometrial Effects Study

This study has been completed.
Information provided by (Responsible Party):
Bayer Identifier:
First received: May 8, 2009
Last updated: November 24, 2014
Last verified: November 2014
The aim of the present study is to investigate the effects of the transdermal patch on the endometrium in healthy women who require contraception.

Condition Intervention Phase
Drug: Ethinylestradiol/Gestogene (BAY86-5016)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Effect on the endometrium at cycle 13 [ Time Frame: 13 treatment cycles (each consisting of 28 days) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • 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 ]

Enrollment: 92
Study Start Date: July 2009
Study Completion Date: August 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 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


Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00896571

Berlin, Germany, 10629
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer Identifier: NCT00896571     History of Changes
Other Study ID Numbers: 14287  2009-010599-45 
Study First Received: May 8, 2009
Last Updated: November 24, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:
Fertility control

Additional relevant MeSH terms:
Contraceptive Agents
Ethinyl Estradiol
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Reproductive Control Agents processed this record on May 26, 2016