Comparative Cycle Control Europe

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00185367
First received: September 13, 2005
Last updated: July 14, 2011
Last verified: July 2011
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:


Further study details as provided by Bayer:

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

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

Enrollment: 798
Study Start Date: March 2005
Study Completion Date: September 2006
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00185367

Locations
Czech Republic
Soukroma gynekologicka ambulance
Fulnek, Czech Republic, 74245
Soukroma gynekologicka ambulance
Ostrava - Zabreh, Czech Republic, 70400
Soukroma gynekologicka ambulance
Plzen, Czech Republic, 30708
Femina Sana s.r.o
Praha, Czech Republic, 13000
Provozorna Gynekologicka ordinace Dr. Tesar
Praha 10, Czech Republic, 109 00
France
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
Germany
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 Hr. Prof. Dr. H.-J. Ahrendt
Magdeburg, Sachsen-Anhalt, Germany, 39126
Praxis Fr. Dr. A. Braune
Magdeburg, Sachsen-Anhalt, Germany, 39104
Praxis Fr. R. Hellmich
Dresden, Sachsen, Germany, 01187
Praxis Fr. Dr. K. Kopprasch
Dresden, Sachsen, Germany, 01169
Praxis Fr. Dr. A. Münzberger
Döbeln, Sachsen, Germany, 04720
Praxis Fr. Dr. C. Burgkhardt
Leipzig, Sachsen, Germany, 04299
Frauenarztpraxis Dr. Bernd Pittner
Leipzig, Sachsen, Germany, 04207
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
Frauenarztpraxis Hr. Dr. B. Hamann
Berlin, Germany, 13187
Praxis Hr. Dr. Karl-Heinz Belling
Berlin, Germany, 13086
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided by Bayer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Therapeutic Area Head, Bayer Healthcare AG
ClinicalTrials.gov Identifier: NCT00185367     History of Changes
Other Study ID Numbers: 90883, EudraCT: 2004-001613-34, 304004
Study First Received: September 13, 2005
Last Updated: July 14, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on July 10, 2014