check_circleStudy Completed

Contraception

Bayer Identifier:

13082

ClinicalTrials.gov Identifier:

NCT00984789

EudraCT Number:

2008-007308-27

EU CT Number:

Not Available
Birth Control Patch Study

Trial purpose

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.

Key Participants Requirements

Sex

Female

Age

18 - 35 Years
  • - 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
  • - 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

Trial summary

Enrollment Goal
393
Trial Dates
May 2009 - September 2010
Phase
Phase 3
Could I Receive a placebo
No
Products
Gestodene/EE Patch (BAY86-5016)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
HEERLEN, 6401 MB, Netherlands
Completed
DEN HELDER, 1782 GZ, Netherlands
Completed
NIJMEGEN, 6525 EC, Netherlands
Completed
Brno, 602 00, Czech Republic
Completed
Ceske Budejovice, 37001, Czech Republic
Completed
Praha 7, 170 00, Czech Republic
Completed
Hradec Kralove, 500 02, Czech Republic
Completed
Praha, 13000, Czech Republic
Completed
Praha 10, 109 00, Czech Republic
Completed
Bregenz, 6900, Austria
Completed
Wien, 1050, Austria
Completed
Graz, 8010, Austria
Completed
Mödling, 2340, Austria
Completed
De Bilt, 3731 DN, Netherlands
Completed
Pisek, 39701, Czech Republic
Completed
Olomouc, 772 00, Czech Republic
Completed
Praha 2, 120 00, Czech Republic
Completed
Wien, 1090, Austria
Completed
Graz, 8010, Austria
Completed
Zeltweg, 8740, Austria
Completed
Wörgl, 6300, Austria
Completed
Wiener Neustadt, 2700, Austria
Completed
Innsbruck, 6020, Austria
Completed
Graz, 8036, Austria

Primary Outcome

  • Bleeding Patterns and cycle control
    date_rangeTime Frame:
    7 cycles (each consisting of 28 days)
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Contraceptive efficacy
    date_rangeTime Frame:
    7 cycles (each consisting of 28 days) + follow up period of 14 days
    enhanced_encryption
    Safety Issue:
    no
  • Adverse Event Collection
    date_rangeTime Frame:
    7 cycles (each consisting of 28 days)
    enhanced_encryption
    Safety Issue:
    yes
  • Population pharmacokinetics
    date_rangeTime Frame:
    7 cycles (each consisting of 28 days)
    enhanced_encryption
    Safety Issue:
    no
  • Compliance to treatment
    date_rangeTime Frame:
    7 cycles (each consisting of 28 days)
    enhanced_encryption
    Safety Issue:
    no
  • Subjective assessment of treatment
    date_rangeTime Frame:
    7 cycles (each consisting of 28 days)
    enhanced_encryption
    Safety Issue:
    no

Trial design

Transdermal contraception patch: EU cycle control study versus EVRA
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Prevention
Allocation
Randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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