Birth Control Patch Study

Transdermal Contraception Patch: EU Cycle Control Study Versus EVRA

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00984789

Enrollment

393

Registered

2009-09-25

Start date

2009-05-31

Completion date

2010-09-30

Last updated

2014-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraception

Keywords

Transdermal Patch, Bleeding, Pregnancy

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.

Interventions

DRUGEthinylestradiol/Gestodene (FC Patch Low BAY86-5016)

0.55mg ethinylestradiol and 2.1mg gestodene

DRUGNorelgestromin/Ethinylestradiol (EVRA)

0.6mg ethinylestradiol and 6mg norelgestromin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 35 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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)

Countries

Austria, Czechia, Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026