FC Patch Comparator Study

NCT ID: NCT00185354

Last Updated: 2015-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

422 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2006-04-30

Brief Summary

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The purpose of this study is to compare bleeding pattern and safety of contraceptive patch SH P00331F to a marketed comparator.

Detailed Description

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The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Conditions

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Contraception

Keywords

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FC patch comparator study

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Arm 1

Group Type EXPERIMENTAL

BAY86-5016, SH P00331F

Intervention Type DRUG

Drug amount per patch: 0.9 mg EE2 + 1.9 mg gestodene (GSD)

Arm 2

Group Type ACTIVE_COMPARATOR

SH P00331N

Intervention Type DRUG

Drug amount per patch: 0.6 mg EE2 + 6 mg NGM

Interventions

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BAY86-5016, SH P00331F

Drug amount per patch: 0.9 mg EE2 + 1.9 mg gestodene (GSD)

Intervention Type DRUG

SH P00331N

Drug amount per patch: 0.6 mg EE2 + 6 mg NGM

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy female volunteer aged 18-35, smokers 18-30

Exclusion Criteria

* Contraindications for using hormonal contraceptives
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Wörgl, Tyrol, Austria

Site Status

Bregenz, , Austria

Site Status

Graz, , Austria

Site Status

Vienna, , Austria

Site Status

Vienna, , Austria

Site Status

Zeltweg, , Austria

Site Status

Helsinki, , Finland

Site Status

Helsinki, , Finland

Site Status

Turku, , Finland

Site Status

Turku, , Finland

Site Status

Paris, Paris, France

Site Status

Biarritz, , France

Site Status

Bordeaux, , France

Site Status

Compiègne, , France

Site Status

Compiègne, , France

Site Status

Maisons Lafitte, , France

Site Status

Montargis, , France

Site Status

Nancy, , France

Site Status

Pantin, , France

Site Status

Roanne, , France

Site Status

Saint-Germain-en-Laye, , France

Site Status

Toulouse, , France

Site Status

San Fernando, Cádiz, Spain

Site Status

Pontevedra, Galicia, Spain

Site Status

Salt, Girona, Spain

Site Status

Guadalajara, Guadalajara, Spain

Site Status

Barcelona, , Spain

Site Status

Santiago de Compostela, , Spain

Site Status

Countries

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Austria Finland France Spain

Related Links

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http://www.clinicaltrialsregister.eu/

Click here to find information about studies related to Bayer Healthcare products conducted in Europe.

Other Identifiers

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2004-000821-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

307969

Identifier Type: OTHER

Identifier Source: secondary_id

91402

Identifier Type: -

Identifier Source: org_study_id