Trial Condition(s):

Oral Contraceptive

Bleeding pattern study

Bayer Identifier:

91227

ClinicalTrials.gov Identifier:

NCT00302666

EudraCT Number:

Not Available

EU CT Number:

Not Available

Study Completed

Trial Purpose

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.

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.

Trial Summary

Enrollment Goal
1315
Trial Dates
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Phase
3
Could I receive a placebo?
No
Products
Valette (Dienogest/EE30, BAY86-5038)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Locations
Locations

Kreiskrankenhaus Krumbach

Krumbach, Germany, 86381

Locations

Praxis Fr. Dr. I. Bayer

Berlin, Germany, 10117

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Frauenarztpraxis Hr. Dr. B. Hamann

Berlin, Germany, 13187

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Praxis Fr. Dr. B. Heuberger

Berlin, Germany, 12587

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Praxis Hr. Dr. R. Humke

Hamburg, Germany, 22041

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Praxis Hr. Dr. Werner Göttker-Schnetmann

Frankfurt, Germany, 60322

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Praxis Hr. Dr. P.-D. Kaeufer

Kelkheim, Germany, 65779

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Praxis Dr. Larbig

Fulda, Germany, 36037

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Praxis Fr. Dr. J. Schmidt-Pich

Hannover, Germany, 30159

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Praxis Hr. Dr. M. Laubscher

Speyer, Germany, 67346

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Praxis Fr. Dr. C. Burgkhardt

Leipzig, Germany, 04299

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Praxis Fr. R. Hellmich

Dresden, Germany, 01187

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Praxis Fr. Dr. K. Kopprasch

Dresden, Germany, 01169

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Praxis Fr. Dr. A. Münzberger

Döbeln, Germany, 04720

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

Magdeburg, Germany, 39126

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Praxis Fr. Dr. A. Braune

Magdeburg, Germany, 39104

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Praxis Fr. Dr. S. Dreissig

Magdeburg, Germany, 39118

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Praxis Fr. A. Heweker

Bernburg, Germany, 06406

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Praxis Hr. Dr. R. Etzrodt

Gera, Germany, 07545

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Praxis Fr. Dr. S. Krepler

Jena, Germany, 07747

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Praxis Fr. Dr. A.Mönch-Hering

Kahla, Germany, 07768

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Frauenarztpraxis Fr. Dr. H. Schlegel

Saalfeld, Germany, 07318

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Praxis Fr. Dr. J. Wartner

Eisenberg, Germany, 07607

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Praxis Hr. Dr. K. Diegritz

Eberbach, Germany, 69412

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Frauenarztpraxis Dr. Buchberger

Neubiberg, Germany, 85579

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Praxis Hr. Dr. R. Kuett

Nürnberg, Germany, 90491

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Praxis Hr. Dr. E. Ranger

Höchstadt a. d. Aisch, Germany, 91315

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Praxis Hr. Dr. Karl-Heinz Belling

Berlin, Germany, 13086

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Frauenarztpraxis Hr. Dr. H. Lindecke

Berlin, Germany, 10247

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Praxis Hr. Dr. D. Rautenberg

Hamburg, Germany, 21073

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Frauenarztpraxis Dr. med. Wolfram Brach

Dietzenbach, Germany, 63128

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Praxis Dr. Kindt

Langen, Germany, 63225

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Praxis Hr. Dr. P. Schwaner

Frankfurt, Germany, 65936

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Praxis Fr. Dr. J. Tyagi

Mühlheim, Germany, 63165

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Klinikum der Johann Wolfgang Goethe Universität

Frankfurt, Germany, 60596

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Praxis Dr. M. Truderung

Neustrelitz, Germany, 17235

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Praxis Hr. Dr. K. Greven

Hannover, Germany, 30459

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Praxis Hr. Dr. H. Beutnagel

Ronnenberg, Germany, 30952

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Praxis Hr. Dr. H. Schreiber

Kirchheimbolanden, Germany, 67292

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Praxis Fr. Dr. C. Biesold

Leipzig, Germany, 04315

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Praxis Fr. I. Gröger

Wurzen, Germany, 04808

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Frauenarztpraxis Dr. Bernd Pittner

Leipzig, Germany, 04207

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Praxis Fr. Dr. R. Schneiderat

Magdeburg, Germany, 39108

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Praxis Hr. H. Thelen

Jessen, Germany, 06917

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Frauenarztpraxis Dr. med. Gabriele Weinreich

Magdeburg, Germany, 39130

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Frauenarztpraxis Dr. Wetzel

Blankenburg, Germany, 38889

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Praxis Hr. R. Wähnert

Gera, Germany, 07545

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Praxis Hr. Dr. A. H. Alashkar

Gevelsberg, Germany, 58285

Locations

Praxis Fr. Dr. K. Demandt

Gütersloh, Germany, 33330

Trial Design