Birth Control Patch Study

Bayer

Status and phase: Completed; Phase 3

Conditions: Contraception

Treatments: Drug: Ethinylestradiol/Gestodene (FC Patch Low BAY86-5016); Drug: Norelgestromin/Ethinylestradiol (EVRA)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00984789

13082

2008-007308-27 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 393 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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393 participants in 2 patient groups

Arm 1

Experimental group

Treatment:

Drug: Ethinylestradiol/Gestodene (FC Patch Low BAY86-5016)

Arm 2

Active Comparator group

Treatment:

Drug: Norelgestromin/Ethinylestradiol (EVRA)