Status:

COMPLETED

Birth Control Patch Study

Lead Sponsor:

Bayer

Collaborating Sponsors:

Parexel

Conditions:

Contraception

Eligibility:

FEMALE

18-35 years

Phase:

PHASE3

Brief Summary

400 healthy women needed contraception will be asked to participate in this study. Half will be given EVRA, half will be given FC Patch low. They will be expected to apply the patches for 21 days of t...

Eligibility Criteria

Inclusion

  • Healthy women requesting contraception aged 18-35 years old
  • Smokers must not be older than 30 at time of informed consent
  • History of regular cyclic menstrual periods, normal cervical smear

Exclusion

  • Pregnancy or lactation
  • Obesity (BMI\>30), hypersensitivity to any ingredients of the study drug, significant skin reaction to transdermal preparations, any diseases/conditions that can compromise the functions of the body system (resulting in altered absorption/accumulation/ metabolism/excretion of the study drug), any diseases / conditions that may worsen under hormonal treatment

Key Trial Info

Start Date :

May 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 1 2010

Estimated Enrollment :

393 Patients enrolled

Trial Details

Trial ID

NCT00984789

Start Date

May 1 2009

End Date

September 1 2010

Last Update

April 2 2014

Active Locations (23)

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Page 1 of 6 (23 locations)

1

Mödling, Lower Austria, Austria, 2340

2

Wiener Neustadt, Lower Austria, Austria, 2700

3

Graz, Styria, Austria, 8036

4

Wörgl, Tyrol, Austria, 6300