Birth Control Patch Study

April 1, 2014 updated by: Bayer

Transdermal Contraception Patch: EU Cycle Control Study Versus EVRA

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 their cycle, for 7 cycles in total. The study will compare the patterns of menstrual bleeding on these two treatments, plus how effective they are at preventing pregnancy, general safety, and their acceptability to the participants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

393

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8010
      • Innsbruck, Austria, 6020
      • Wien, Austria, 1090
      • Wien, Austria, 1050
      • Zeltweg, Austria, 8740
    • Niederösterreich
      • Mödling, Niederösterreich, Austria, 2340
      • Wiener Neustadt, Niederösterreich, Austria, 2700
    • Steiermark
      • Graz, Steiermark, Austria, 8036
    • Tirol
      • Wörgl, Tirol, Austria, 6300
    • Vorarlberg
      • Bregenz, Vorarlberg, Austria, 6900
  • Czech Republic
      • Brno, Czech Republic, 602 00
      • Ceske Budejovice, Czech Republic, 37001
      • Hradec Kralove, Czech Republic, 500 02
      • Olomouc, Czech Republic, 77900
      • Pisek, Czech Republic, 39701
      • Praha, Czech Republic, 13000
      • Praha 10, Czech Republic, 109 00
      • Praha 2, Czech Republic, 120 00
      • Praha 7, Czech Republic, 170 00
  • Netherlands
      • De Bilt, Netherlands, 3731 DN
      • Den Helder, Netherlands, 1782 GZ
      • Heerlen, Netherlands, 6401 MB
      • Nijmegen, Netherlands, 6525 EC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm 2
Drug: Norelgestromin/Ethinylestradiol (EVRA)
0.6mg ethinylestradiol and 6mg norelgestromin
Experimental: Arm 1
Drug: Ethinylestradiol/Gestodene (FC Patch Low BAY86-5016)
0.55mg ethinylestradiol and 2.1mg gestodene

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bleeding Patterns and cycle control
Time Frame: 7 cycles (each consisting of 28 days)
7 cycles (each consisting of 28 days)

Secondary Outcome Measures

Outcome Measure
Time Frame
Contraceptive efficacy
Time Frame: 7 cycles (each consisting of 28 days) + follow up period of 14 days
7 cycles (each consisting of 28 days) + follow up period of 14 days
Adverse Event Collection
Time Frame: 7 cycles (each consisting of 28 days)
7 cycles (each consisting of 28 days)
Population pharmacokinetics
Time Frame: 7 cycles (each consisting of 28 days)
7 cycles (each consisting of 28 days)
Compliance to treatment
Time Frame: 7 cycles (each consisting of 28 days)
7 cycles (each consisting of 28 days)
Subjective assessment of treatment
Time Frame: 7 cycles (each consisting of 28 days)
7 cycles (each consisting of 28 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Collaborators

Parexel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

September 4, 2009

First Submitted That Met QC Criteria

September 24, 2009

First Posted (Estimate)

September 25, 2009

Study Record Updates

Last Update Posted (Estimate)

April 2, 2014

Last Update Submitted That Met QC Criteria

April 1, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13082
  • 2008-007308-27 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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