Comparative Cycle Control Europe

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00185367
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : July 15, 2011
Information provided by:

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Contraception Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658K) Drug: SH D 593 B (Miranova) Phase 3

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 798 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Multi-center, Double-blind, Double-dummy, Controlled, Randomized Study to Evaluate Cycle Control and Safety of a Four Phasic Oral Contraceptive (SH T00658ID) in Comparison to an Oral Contraceptive Containing Ethinylestradiol and Levonorgestrel (SH D 593 B) in Healthy Female Volunteers Aged Between 18 and 50 Years.
Study Start Date : March 2005
Actual Study Completion Date : September 2006

Arm Intervention/treatment
Experimental: Arm 1 Drug: 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
Active Comparator: Arm 2 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

Primary Outcome Measures :
  1. Bleeding pattern [ Time Frame: 7 treatment cycles each consisting of 28 days ]
  2. Number of unintended pregnancies [ Time Frame: 7 treatment cycles each consisting of 28 days and follow-up period of 14 days ]

Secondary Outcome Measures :
  1. Adverse event collection [ Time Frame: 7 treatment cycles each consisting of 28 days and follow-up period of 14 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00185367

Czech Republic
Soukroma gynekologicka ambulance
Fulnek, Czech Republic, 74245
Soukroma gynekologicka ambulance
Ostrava - Zabreh, Czech Republic, 70400
Soukroma gynekologicka ambulance
Plzen, Czech Republic, 30708
Provozorna Gynekologicka ordinace Dr. Tesar
Praha 10, Czech Republic, 109 00
Femina Sana s.r.o
Praha, Czech Republic, 13000
Dr. Jocelyne Nataf-Maurin
Brignoles, France, 83170
Dr. Marie-Helene Malbranche-Aupecle
Dijon, France, 21000
Centre Hospitalier de l Estuaire
Honfleur, France, 14601
Dr. Annette Mercier
Morlaix, France, 29600
Clinique d Occitanie
Muret, France, 31600
Centre Medical du Val de Loire
Nevers, France, 58000
Dr. Anne-Isabelle Richet
Paris, France, 75007
Cabinet medical
Quetigny, France, 21800
Dr. Gwendoline Servan
Tarare, France, 69170
Dr. Aliette Siboni-Frisch
Toulouse, France, 31000
Frauenarztpraxis Dr. Buchberger
Neubiberg, Bayern, Germany, 85579
Praxis Hr. Dr. R. Kuett
Nürnberg, Bayern, Germany, 90491
Praxis Dr. Larbig
Fulda, Hessen, Germany, 36037
Praxis Fr. Dr. J. Schmidt-Pich
Hannover, Niedersachsen, Germany, 30159
Frauenarztpraxis Dr. Wetzel
Blankenburg, Sachsen-Anhalt, Germany, 38889
Frauenarztpraxis Dipl. med. Michael Stellmacher
Burg, Sachsen-Anhalt, Germany, 39288
Praxis Fr. Dr. A. Braune
Magdeburg, Sachsen-Anhalt, Germany, 39104
Praxis Hr. Prof. Dr. H.-J. Ahrendt
Magdeburg, Sachsen-Anhalt, Germany, 39126
Praxis Fr. Dr. K. Kopprasch
Dresden, Sachsen, Germany, 01169
Praxis Fr. R. Hellmich
Dresden, Sachsen, Germany, 01187
Praxis Fr. Dr. A. Münzberger
Döbeln, Sachsen, Germany, 04720
Frauenarztpraxis Dr. Bernd Pittner
Leipzig, Sachsen, Germany, 04207
Praxis Fr. Dr. C. Burgkhardt
Leipzig, Sachsen, Germany, 04299
Praxis Hr. R. Wähnert
Gera, Thüringen, Germany, 07545
Praxis Fr. Dr. A.Mönch-Hering
Kahla, Thüringen, Germany, 07768
Frauenarztpraxis Hr. Dr. H. Lindecke
Berlin, Germany, 10247
Praxis Fr. Dr. B. Heuberger
Berlin, Germany, 12587
Praxis Hr. Dr. Karl-Heinz Belling
Berlin, Germany, 13086
Frauenarztpraxis Hr. Dr. B. Hamann
Berlin, Germany, 13187
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer