Comparative Cycle Control Europe

Phase 3

Completed

• Conditions: Contraception
• Interventions: Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658K); Drug: SH D 593 B (Miranova)

• Registration Number: NCT00185367
• Lead Sponsor: Bayer

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.

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 Timeline

• Study Start: 2005-03
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-16
• Study Completion: 2006-09
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-14
• Last Update Posted: 2011-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 798

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	EV/DNG (Qlaira, BAY86-5027, SH T00658K)	-
Arm 2	SH D 593 B (Miranova)	-

Primary Outcome Measures

Name	Time	Method
Bleeding pattern	7 treatment cycles each consisting of 28 days
Number of unintended pregnancies	7 treatment cycles each consisting of 28 days and follow-up period of 14 days

Secondary Outcome Measures

Name	Time	Method
Adverse event collection	7 treatment cycles each consisting of 28 days and follow-up period of 14 days

Trial Locations

Locations (32)

Dr. Gwendoline Servan; 🇫🇷 Tarare, France

Provozorna Gynekologicka ordinace Dr. Tesar; 🇨🇿 Praha 10, Czech Republic

Dr. Jocelyne Nataf-Maurin; 🇫🇷 Brignoles, France

Femina Sana s.r.o; 🇨🇿 Praha, Czech Republic

Soukroma gynekologicka ambulance; 🇨🇿 Plzen, Czech Republic

Dr. Annette Mercier; 🇫🇷 Morlaix, France

Centre Hospitalier de l Estuaire; 🇫🇷 Honfleur, France

Dr. Marie-Helene Malbranche-Aupecle; 🇫🇷 Dijon, France

Centre Medical du Val de Loire; 🇫🇷 Nevers, France

Dr. Anne-Isabelle Richet; 🇫🇷 Paris, France

Cabinet medical; 🇫🇷 Quetigny, France

Dr. Aliette Siboni-Frisch; 🇫🇷 Toulouse, France

Frauenarztpraxis Dr. Buchberger; 🇩🇪 Neubiberg, Bayern, Germany

Praxis Hr. Dr. R. Kuett; 🇩🇪 Nürnberg, Bayern, Germany

Praxis Dr. Larbig; 🇩🇪 Fulda, Hessen, Germany

Praxis Fr. Dr. J. Schmidt-Pich; 🇩🇪 Hannover, Niedersachsen, Germany

Frauenarztpraxis Dipl. med. Michael Stellmacher; 🇩🇪 Burg, Sachsen-Anhalt, Germany

Praxis Hr. Prof. Dr. H.-J. Ahrendt; 🇩🇪 Magdeburg, Sachsen-Anhalt, Germany

Praxis Fr. Dr. A. Braune; 🇩🇪 Magdeburg, Sachsen-Anhalt, Germany

Praxis Fr. Dr. A. Münzberger; 🇩🇪 Döbeln, Sachsen, Germany

Praxis Fr. Dr. K. Kopprasch; 🇩🇪 Dresden, Sachsen, Germany

Frauenarztpraxis Dr. Bernd Pittner; 🇩🇪 Leipzig, Sachsen, Germany

Praxis Fr. R. Hellmich; 🇩🇪 Dresden, Sachsen, Germany

Praxis Fr. Dr. C. Burgkhardt; 🇩🇪 Leipzig, Sachsen, Germany

Praxis Hr. R. Wähnert; 🇩🇪 Gera, Thüringen, Germany

Praxis Fr. Dr. A.Mönch-Hering; 🇩🇪 Kahla, Thüringen, Germany

Frauenarztpraxis Hr. Dr. H. Lindecke; 🇩🇪 Berlin, Germany

Praxis Hr. Dr. Karl-Heinz Belling; 🇩🇪 Berlin, Germany

Frauenarztpraxis Hr. Dr. B. Hamann; 🇩🇪 Berlin, Germany

Praxis Fr. Dr. B. Heuberger; 🇩🇪 Berlin, Germany

Frauenarztpraxis Dr. Wetzel; 🇩🇪 Blankenburg, Sachsen-Anhalt, Germany

Clinique d Occitanie; 🇫🇷 Muret, France