Bleeding Pattern Study

NCT ID: NCT00302666

Last Updated: 2009-05-18

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

1315 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2005-02-28

Brief Summary

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The aim of this study is to evaluate bleeding pattern, cycle control, contraceptive efficacy and safety of this oral contraceptive in two different regimens of intake.

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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Oral Contraceptive

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 SHAM_COMPARATOR

Valette (Dienogest/EE30, BAY86-5038)

Intervention Type DRUG

Oral contraceptive extended cycles

Arm 2

Group Type SHAM_COMPARATOR

Valette (Dienogest/EE30, BAY86-5038)

Intervention Type DRUG

Oral contraceptive conventional cycles

Interventions

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Valette (Dienogest/EE30, BAY86-5038)

Oral contraceptive extended cycles

Intervention Type DRUG

Valette (Dienogest/EE30, BAY86-5038)

Oral contraceptive conventional cycles

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy female volunteers aged between 18 and 40 years requiring contraception.

Exclusion Criteria

* Pregnancy or lactation.
* Any conditions that might interfere with the outcome as well as all contraindications for OC use.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Bayer Schering Pharma AG

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Eberbach, Baden-Wurttemberg, Germany

Site Status

Höchstadt A. D. Aisch, Bavaria, Germany

Site Status

Krumbach, Bavaria, Germany

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Neubiberg, Bavaria, Germany

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Nuremberg, Bavaria, Germany

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Hamburg, City state of Hamburg, Germany

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Hamburg, City state of Hamburg, Germany

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Dietzenbach, Hesse, Germany

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Frankfurt am Main, Hesse, Germany

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Frankfurt am Main, Hesse, Germany

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Frankfurt am Main, Hesse, Germany

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Fulda, Hesse, Germany

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Kelkheim, Hesse, Germany

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Langen, Hesse, Germany

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Mühlheim am Main, Hesse, Germany

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Hanover, Lower Saxony, Germany

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Hanover, Lower Saxony, Germany

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Ronnenberg, Lower Saxony, Germany

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Neustrelitz, Mecklenburg-Vorpommern, Germany

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Gevelsberg, North Rhine-Westphalia, Germany

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Gütersloh, North Rhine-Westphalia, Germany

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Kirchheimbolanden, Rhineland-Palatinate, Germany

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Speyer, Rhineland-Palatinate, Germany

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Döbeln, Saxony, Germany

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Dresden, Saxony, Germany

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Dresden, Saxony, Germany

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Leipzig, Saxony, Germany

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Leipzig, Saxony, Germany

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Leipzig, Saxony, Germany

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Wurzen, Saxony, Germany

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Bernburg, Saxony-Anhalt, Germany

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Blankenburg, Saxony-Anhalt, Germany

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Jessen, Saxony-Anhalt, Germany

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Magdeburg, Saxony-Anhalt, Germany

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Magdeburg, Saxony-Anhalt, Germany

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Magdeburg, Saxony-Anhalt, Germany

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Magdeburg, Saxony-Anhalt, Germany

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Magdeburg, Saxony-Anhalt, Germany

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Berlin, State of Berlin, Germany

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Berlin, State of Berlin, Germany

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Berlin, State of Berlin, Germany

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Berlin, State of Berlin, Germany

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Berlin, State of Berlin, Germany

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Eisenberg, Thuringia, Germany

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Gera, Thuringia, Germany

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Jena, Thuringia, Germany

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Kahla, Thuringia, Germany

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Saalfeld, Thuringia, Germany

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Countries

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Germany

Other Identifiers

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306903

Identifier Type: -

Identifier Source: secondary_id

91227

Identifier Type: -

Identifier Source: org_study_id

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