Comparative Cycle Control Europe

July 14, 2011 updated by: Bayer

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

798

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bleeding pattern
Time Frame: 7 treatment cycles each consisting of 28 days
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
7 treatment cycles each consisting of 28 days and follow-up period of 14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse event collection
Time Frame: 7 treatment cycles each consisting of 28 days and follow-up period of 14 days
7 treatment cycles each consisting of 28 days and follow-up period of 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Study Completion (Actual)

September 1, 2006

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Estimate)

July 15, 2011

Last Update Submitted That Met QC Criteria

July 14, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Other Study ID Numbers

  • 90883
  • EudraCT: 2004-001613-34
  • 304004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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