EU/LA Pearl Index Study - Transdermal Contraceptive Patch

Phase 3

Completed

• Conditions: Contraception
• Interventions: Drug: Ethinylestradiol/Gestodene (BAY86-5016)

• Registration Number: NCT00914693
• Lead Sponsor: Bayer

Brief Summary

The aim of the present study is to prove efficacy and safety of a new contraceptive patch.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-05-05
• Study First Submitted QC: 2009-06-04
• Study First Posted: 2009-06-05
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-04
• Last Update Posted: 2014-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1694

Inclusion Criteria

• Requiring contraception
• Normal cervical smear
• Smokers not older than 30 years
• History of regular cyclic menstrual periods

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Exclusion Criteria

• Pregnancy or lactation
• Obesity (BMI> 30 kg/m2
• Significant skin reaction to transdermal preparations or sensitivity to surgical / medical tape
• Any disease that may worsen under hormonal treatment (cardiovascular, liver, metabolic)
• Use of other contraceptive methods than study medication

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	Ethinylestradiol/Gestodene (BAY86-5016)	-

Primary Outcome Measures

Name	Time	Method
Occurrence of pregnancy	13 treatment cycles each consisting of 28 days and follow-up period of 14 days

Secondary Outcome Measures

Name	Time	Method
Cervical smear	13 treatment cycles each consisting of 28 days
Adverse events	13 treatment cycles each consisting of 28 days
Bleeding pattern and cycle control	13 treatment cycles each consisting of 28 days