Clinical trial NCT00984789: Birth Control Patch Study
Official title: Transdermal Contraception Patch: EU Cycle Control Study Versus EVRA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Contraception
Keywords: Transdermal Patch
Bleeding
Pregnancy
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Parexel
First posted: 2009-09-25
Enrollment: 393
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Bleeding Patterns and cycle control
timeFrame: 7 cycles (each consisting of 28 days)
Secondary outcomes:
measure: Contraceptive efficacy
timeFrame: 7 cycles (each consisting of 28 days) + follow up period of 14 days
measure: Adverse Event Collection
timeFrame: 7 cycles (each consisting of 28 days)
measure: Population pharmacokinetics
timeFrame: 7 cycles (each consisting of 28 days)
measure: Compliance to treatment
timeFrame: 7 cycles (each consisting of 28 days)
measure: Subjective assessment of treatment
timeFrame: 7 cycles (each consisting of 28 days)
Other outcomes:
Locations:
city: Mödling
country: Austria
state: Niederösterreich
city: Wiener Neustadt
country: Austria
state: Niederösterreich
city: Graz
country: Austria
state: Steiermark
city: Wörgl
country: Austria
state: Tirol
city: Bregenz
country: Austria
state: Vorarlberg
city: Graz
country: Austria
city: Innsbruck
country: Austria
city: Wien
country: Austria
city: Wien
country: Austria
city: Zeltweg
country: Austria
city: Brno
country: Czech Republic
city: Ceske Budejovice
country: Czech Republic
city: Hradec Kralove
country: Czech Republic
city: Olomouc
country: Czech Republic
city: Pisek
country: Czech Republic
city: Praha 10
country: Czech Republic
city: Praha 2
country: Czech Republic
city: Praha 7
country: Czech Republic
city: Praha
country: Czech Republic
city: De Bilt
country: Netherlands
city: Den Helder
country: Netherlands
city: Heerlen
country: Netherlands
city: Nijmegen
country: Netherlands
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: 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.