EU/LA Pearl Index Study - Transdermal Contraceptive Patch

Phase 3CompletedNCT00914693

Bayer1,694 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

1,694

Conditions

Contraception

Interventions

Ethinylestradiol/Gestodene (BAY86-5016)DRUG

7-day patch containing 0.55 mg ethinylestradiol (EE) and 2.1 mg gestodene (GSD) in a 21-day regimen

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 35 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Requiring contraception * Normal cervical smear * Smokers not older than 30 years * History of regular cyclic menstrual periods 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

Locations (66)

Outcomes

Primary Outcomes

Occurrence of pregnancy

Time frame: 13 treatment cycles each consisting of 28 days and follow-up period of 14 days

Secondary Outcomes

Cervical smear

Time frame: 13 treatment cycles each consisting of 28 days

Adverse events

Time frame: 13 treatment cycles each consisting of 28 days

Bleeding pattern and cycle control

Time frame: 13 treatment cycles each consisting of 28 days

Data from ClinicalTrials.gov

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Lanús Oeste, Buenos Aires, Argentina

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San Isidro, Buenos Aires, Argentina

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Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina

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Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina

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Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina

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Rosario, Santa Fe Province, Argentina

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Ashfield, New South Wales, Australia

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Adelaide, South Australia, Australia

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North Adelaide, South Australia, Australia

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Clayton, Victoria, Australia

...and 56 more locations