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Comparative Cycle Control Europe

NCT ID: NCT00185367

Last Updated: 2011-07-15

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

798 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2006-09-30

Brief Summary

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The aim of this study is to evaluate bleeding pattern, cycle control, and safety of this new four-phasic oral contraceptive in comparison to a reference OC.

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm 1

Group Type EXPERIMENTAL

EV/DNG (Qlaira, BAY86-5027, SH T00658K)

Intervention Type DRUG

7 cycles each consisting of 28 days (no tablet-free intervals); Day 1-2: 3.0 mg EV; Day 3-7: 2.0 mg EV + 2.0 mg DNG; Day 8-24: 2.0 mg EV + 3.0 mg DNG; Day 25-26: 1.0 mg EV; Day 27-28: placebo;In addition SH D 593 B (Miranova) matching placebo

Arm 2

Group Type ACTIVE_COMPARATOR

SH D 593 B (Miranova)

Intervention Type DRUG

7 cycles each consisting of 28 days (no tablet-free intervals); Day 1-21: 0.02 mg EE + 0.10 mg LNG; Day 22-28: placebo; In addition EV/DNG (Qlaira, BAY86-5027, SH T00658K) matching placebo

Interventions

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EV/DNG (Qlaira, BAY86-5027, SH T00658K)

7 cycles each consisting of 28 days (no tablet-free intervals); Day 1-2: 3.0 mg EV; Day 3-7: 2.0 mg EV + 2.0 mg DNG; Day 8-24: 2.0 mg EV + 3.0 mg DNG; Day 25-26: 1.0 mg EV; Day 27-28: placebo;In addition SH D 593 B (Miranova) matching placebo

Intervention Type DRUG

SH D 593 B (Miranova)

7 cycles each consisting of 28 days (no tablet-free intervals); Day 1-21: 0.02 mg EE + 0.10 mg LNG; Day 22-28: placebo; In addition EV/DNG (Qlaira, BAY86-5027, SH T00658K) matching placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy female volunteers aged between 18 and 50 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

50 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 Healthcare AG

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Soukroma gynekologicka ambulance

Fulnek, , Czechia

Site Status

Soukroma gynekologicka ambulance

Pilsen, , Czechia

Site Status

Provozorna Gynekologicka ordinace Dr. Tesar

Prague, , Czechia

Site Status

Femina Sana s.r.o

Prague, , Czechia

Site Status

Soukroma gynekologicka ambulance

Zábřeh nad Odrou, , Czechia

Site Status

Dr. Jocelyne Nataf-Maurin

Brignoles, , France

Site Status

Dr. Marie-Helene Malbranche-Aupecle

Dijon, , France

Site Status

Centre Hospitalier de l Estuaire

Honfleur, , France

Site Status

Dr. Annette Mercier

Morlaix, , France

Site Status

Clinique d Occitanie

Muret, , France

Site Status

Centre Medical du Val de Loire

Nevers, , France

Site Status

Dr. Anne-Isabelle Richet

Paris, , France

Site Status

Cabinet medical

Quetigny, , France

Site Status

Dr. Gwendoline Servan

Tarare, , France

Site Status

Dr. Aliette Siboni-Frisch

Toulouse, , France

Site Status

Frauenarztpraxis Dr. Buchberger

Neubiberg, Bavaria, Germany

Site Status

Praxis Hr. Dr. R. Kuett

Nuremberg, Bavaria, Germany

Site Status

Praxis Dr. Larbig

Fulda, Hesse, Germany

Site Status

Praxis Fr. Dr. J. Schmidt-Pich

Hanover, Lower Saxony, Germany

Site Status

Praxis Fr. Dr. A. Münzberger

Döbeln, Saxony, Germany

Site Status

Praxis Fr. Dr. K. Kopprasch

Dresden, Saxony, Germany

Site Status

Praxis Fr. R. Hellmich

Dresden, Saxony, Germany

Site Status

Frauenarztpraxis Dr. Bernd Pittner

Leipzig, Saxony, Germany

Site Status

Praxis Fr. Dr. C. Burgkhardt

Leipzig, Saxony, Germany

Site Status

Frauenarztpraxis Dr. Wetzel

Blankenburg, Saxony-Anhalt, Germany

Site Status

Frauenarztpraxis Dipl. med. Michael Stellmacher

Burg, Saxony-Anhalt, Germany

Site Status

Praxis Fr. Dr. A. Braune

Magdeburg, Saxony-Anhalt, Germany

Site Status

Praxis Hr. Prof. Dr. H.-J. Ahrendt

Magdeburg, Saxony-Anhalt, Germany

Site Status

Frauenarztpraxis Hr. Dr. H. Lindecke

Berlin, State of Berlin, Germany

Site Status

Praxis Fr. Dr. B. Heuberger

Berlin, State of Berlin, Germany

Site Status

Praxis Hr. Dr. Karl-Heinz Belling

Berlin, State of Berlin, Germany

Site Status

Frauenarztpraxis Hr. Dr. B. Hamann

Berlin, State of Berlin, Germany

Site Status

Praxis Hr. R. Wähnert

Gera, Thuringia, Germany

Site Status

Praxis Fr. Dr. A.Mönch-Hering

Kahla, Thuringia, Germany

Site Status

Countries

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Czechia France Germany

References

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Ahrendt HJ, Makalova D, Parke S, Mellinger U, Mansour D. Bleeding pattern and cycle control with an estradiol-based oral contraceptive: a seven-cycle, randomized comparative trial of estradiol valerate/dienogest and ethinyl estradiol/levonorgestrel. Contraception. 2009 Nov;80(5):436-44. doi: 10.1016/j.contraception.2009.03.018. Epub 2009 May 13.

Reference Type DERIVED
PMID: 19835717 (View on PubMed)

Other Identifiers

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EudraCT: 2004-001613-34

Identifier Type: -

Identifier Source: secondary_id

304004

Identifier Type: -

Identifier Source: secondary_id

90883

Identifier Type: -

Identifier Source: org_study_id

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