Birth Control Patch Study

Bayer393 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

393

Conditions

Contraception

Interventions

Ethinylestradiol/Gestodene (FC Patch Low BAY86-5016)DRUG

0.55mg ethinylestradiol and 2.1mg gestodene

Norelgestromin/Ethinylestradiol (EVRA)DRUG

0.6mg ethinylestradiol and 6mg norelgestromin

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (23)

Unnamed facility

Mödling, Lower Austria, Austria

Unnamed facility

Wiener Neustadt, Lower Austria, Austria

Unnamed facility