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Transdermal Contraceptive Patch - Endometrial Effects Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00896571
First Posted: May 11, 2009
Last Update Posted: November 26, 2014
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.
Information provided by (Responsible Party):
Bayer
  Purpose
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
Contraception Drug: Ethinylestradiol/Gestogene (BAY86-5016) Phase 2

Study Type: Interventional
Study Design: 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

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) ]

Secondary Outcome Measures:
  • 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) ]

Other Outcome Measures:
  • 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) ]

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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 Submitted: May 8, 2009
First Posted: May 11, 2009
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


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