Status:

COMPLETED

Transdermal Contraceptive Patch - Endometrial Effects Study

Lead Sponsor:

Bayer

Conditions:

Contraception

Eligibility:

FEMALE

18-35 years

Phase:

PHASE2

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.

Eligibility Criteria

Inclusion

  • Requiring contraception
  • Normal cervical smear
  • Smokers not older than 30 years
  • History of regular cyclic menstrual periods

Exclusion

  • 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

Key Trial Info

Start Date :

July 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 1 2011

Estimated Enrollment :

92 Patients enrolled

Trial Details

Trial ID

NCT00896571

Start Date

July 1 2009

End Date

August 1 2011

Last Update

November 26 2014

Active Locations (1)

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1

Berlin, State of Berlin, Germany, 10629