Birth Control Patch Study
Transdermal Contraception Patch: EU Cycle Control Study Versus EVRA
2 other identifiers
interventional
393
3 countries
23
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2009
Shorter than P25 for phase_3
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 4, 2009
CompletedFirst Posted
Study publicly available on registry
September 25, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedApril 2, 2014
April 1, 2014
1.3 years
September 4, 2009
April 1, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Bleeding Patterns and cycle control
7 cycles (each consisting of 28 days)
Secondary Outcomes (5)
Contraceptive efficacy
7 cycles (each consisting of 28 days) + follow up period of 14 days
Adverse Event Collection
7 cycles (each consisting of 28 days)
Population pharmacokinetics
7 cycles (each consisting of 28 days)
Compliance to treatment
7 cycles (each consisting of 28 days)
Subjective assessment of treatment
7 cycles (each consisting of 28 days)
Study Arms (2)
Arm 1
EXPERIMENTALArm 2
ACTIVE COMPARATORInterventions
0.55mg ethinylestradiol and 2.1mg gestodene
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Unknown Facility
Mödling, Lower Austria, 2340, Austria
Unknown Facility
Wiener Neustadt, Lower Austria, 2700, Austria
Unknown Facility
Graz, Styria, 8036, Austria
Unknown Facility
Wörgl, Tyrol, 6300, Austria
Unknown Facility
Bregenz, Vorarlberg, 6900, Austria
Unknown Facility
Graz, 8010, Austria
Unknown Facility
Innsbruck, 6020, Austria
Unknown Facility
Vienna, 1050, Austria
Unknown Facility
Vienna, 1090, Austria
Unknown Facility
Zeltweg, 8740, Austria
Unknown Facility
Brno, 602 00, Czechia
Unknown Facility
České Budějovice, 37001, Czechia
Unknown Facility
Hradec Králové, 500 02, Czechia
Unknown Facility
Olomouc, 77900, Czechia
Unknown Facility
Písek, 39701, Czechia
Unknown Facility
Prague, 109 00, Czechia
Unknown Facility
Prague, 120 00, Czechia
Unknown Facility
Prague, 13000, Czechia
Unknown Facility
Prague, 170 00, Czechia
Unknown Facility
De Bilt, 3731 DN, Netherlands
Unknown Facility
Den Helder, 1782 GZ, Netherlands
Unknown Facility
Heerlen, 6401 MB, Netherlands
Unknown Facility
Nijmegen, 6525 EC, Netherlands
Related Publications (1)
Gruber D, Skrivanek A, Serrani M, Lanius V, Merz M. A comparison of bleeding patterns and cycle control using two transdermal contraceptive systems: a multicenter, open-label, randomized study. Contraception. 2015 Feb;91(2):105-12. doi: 10.1016/j.contraception.2014.10.003. Epub 2014 Oct 13.
PMID: 25453582DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 4, 2009
First Posted
September 25, 2009
Study Start
May 1, 2009
Primary Completion
September 1, 2010
Study Completion
September 1, 2010
Last Updated
April 2, 2014
Record last verified: 2014-04