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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):

Study Description
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.

Condition or disease Intervention/treatment Phase
Contraception Drug: Ethinylestradiol/Gestogene (BAY86-5016) Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2009
Primary Completion Date : May 2011
Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Effect on the endometrium at cycle 13 [ Time Frame: 13 treatment cycles (each consisting of 28 days) ]

Secondary Outcome Measures :
  1. Cervical smear [ Time Frame: 13 treatment cycles (each consisting of 28 days) ]
  2. Adverse events [ Time Frame: 13 treatment cycles (each consisting of 28 days) ]
  3. Cycle control [ Time Frame: 13 treatment cycles (each consisting of 28 days) ]
  4. Safety laboratory [ Time Frame: 13 treatment cycles (each consisting of 28 days) ]
  5. Occurence of pregnancy [ Time Frame: 13 treatment cycles (each consisting of 28 days) ]

Other Outcome Measures:
  1. Treatment compliance [ Time Frame: 13 treatment cycles (each consisting of 28 days) ]
  2. Subjective assessment of satisfaction with the treatment [ Time Frame: 13 treatment cycles (each consisting of 28 days) ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00896571


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

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00896571     History of Changes
Other Study ID Numbers: 14287
2009-010599-45 ( EudraCT Number )
First Posted: May 11, 2009    Key Record Dates
Last Update Posted: November 26, 2014
Last Verified: November 2014

Keywords provided by Bayer:
Fertility control
Contraception

Additional relevant MeSH terms:
Contraceptive Agents
Gestodene
Ethinyl Estradiol
Reproductive Control Agents
Physiological Effects of Drugs
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Progestins