Birth Control Patch Study

Phase 3

Completed

• Conditions: Contraception
• Interventions: Drug: Ethinylestradiol/Gestodene (FC Patch Low BAY86-5016); Drug: Norelgestromin/Ethinylestradiol (EVRA)

• Registration Number: NCT00984789
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-09-04
• Study First Submitted QC: 2009-09-24
• Study First Posted: 2009-09-25
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-01
• Last Update Posted: 2014-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 393

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Ethinylestradiol/Gestodene (FC Patch Low BAY86-5016)	-
Arm 2	Norelgestromin/Ethinylestradiol (EVRA)	-

Primary Outcome Measures

Name	Time	Method
Bleeding Patterns and cycle control	7 cycles (each consisting of 28 days)

Secondary Outcome Measures

Name	Time	Method
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)