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
  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
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

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00896571

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

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00896571     History of Changes
Other Study ID Numbers: 14287, 2009-010599-45
Study First Received: May 8, 2009
Last Updated: December 11, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:
Fertility control
Contraception

Additional relevant MeSH terms:
Contraceptive Agents
Ethinyl Estradiol
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014