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ContraceptionPhase 3NCT00185289

Study to Investigate Efficacy and Safety of a New Oral Contraceptive

A Phase 3 study testing EV/DNG (Qlaira, BAY86-5027, SH T00658K) in people with Contraception, run by Bayer at 50 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the safety and effectiveness of a new 4-phasic preparation in the prevention of pregnancies in a large group of volunteers. Read more about this study

Who is it for?
Ages 18 to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for
Contraception
What is being tested?
EV/DNG (Qlaira, BAY86-5027, SH T00658K)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,392 participants
Where
50 sitesin 3 countries
Study dates
Apr 2004to Jul 2006
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy volunteers

Who cannot join

  • Any condition that might interfere the outcomes

Trial locations and contacts

50 sites in 3 countries.

50 sites in 3 countries

Germany27 sites

  • Praxis Hr. Dr. L. Weihe

    Ansbach, Bavaria, 91522

  • Dinox GmbH Berlin

    Berlin, State of Berlin, 10115

  • Charité Campus Benjamin Franklin

    Berlin, State of Berlin, 12200

  • Frauenarztpraxis Fr. Dr. S. Gramatte

    Berlin, State of Berlin, 12435

  • Praxis Fr. Dr. B. Wernecke

    Berlin, State of Berlin, 12435

  • Praxis Fr. Dr. I. Hannig

    Berlin, State of Berlin, 12435

  • Praxis Fr. Dr. K. Maar

    Berlin, State of Berlin, 13507

  • Praxis Hr. Dr. H. Zabel

    Bovenden, Lower Saxony, 37120

  • Frauenarztpraxis Dr. med. Wolfram Brach

    Dietzenbach, Hesse, 63128

  • Praxis Hr. Dr. A. Soder

    Ettlingen, Baden-Wurttemberg, 76275

  • Praxis Hr. Dr. Werner Göttker-Schnetmann

    Frankfurt am Main, Hesse, 60322

  • Praxis Dr. S. El Tobgui-Jensen

    Frankfurt am Main, Hesse, 60439

  • Praxis Dr. S. Clauss-Hoffmann

    Frankfurt am Main, Hesse, 65929

  • Praxis Hr. Dr. P. Schwaner

    Frankfurt am Main, Hesse, 65936

  • Praxis Hr. Dr. R. Etzrodt

    Gera, Thuringia, 07545

  • Praxis Hr. Dr. D. Rautenberg

    Hamburg, Free and Hanseatic City of Hamburg, 21073

  • Praxis Hr. Dr. K. Brauns

    Hamelin, Lower Saxony, 31785

  • Praxis Hr. Dr. K. Greven

    Hanover, Lower Saxony, 30459

  • Praxis Hr. H. Thelen

    Jessen, Saxony-Anhalt, 06917

  • Praxis Hr. Dr. U. Kohoutek

    Karlsruhe, Baden-Wurttemberg, 76199

  • Praxis Dr. Kindt

    Langen, Hesse, 63225

  • Frauenarztpraxis Dr. med. Gabriele Weinreich

    Magdeburg, Saxony-Anhalt, 39130

  • Praxis Fr. Dr. J. Tyagi

    Mühlheim am Main, Hesse, 63165

  • Praxis Hr. Dr. H. Frommeyer

    Osnabrück, Lower Saxony, 49074

  • Frauenarztpraxis Dr. Schoenberg

    Rheine, North Rhine-Westphalia, 48431

  • Frauenarztpraxis Fr. Dr. H. Schlegel

    Saalfeld, Thuringia, 07318

  • Praxis Fr. I. Gröger

    Wurzen, Saxony, 04808

Other trials in Germany

Austria18 sites

  • Landeskrankenhaus Bregenz

    Bregenz, 6900

  • Praxis Dr. Langer

    Fürstenfeld, Styria, 8280

  • Dr. Roswitha Wessely

    Graz, 8010

  • Institut für Hormonstörungen und Kinderwunsch

    Graz, 8010

  • Praxis Dr. Gudrun Lorenz-Eberhard

    Graz, 8010

  • Praxis Dr. Hannes Kahr

    Graz, 8010

  • Universitätsklinikum Innsbruck

    Innsbruck, 6020

  • Dr. Peter Mayr

    Kufstein, 6330

  • Dr. Michaela Boeckl

    Salzburg, 5020

  • Dr. Sigrid Schmidl-Amann

    Sankt Pölten, 3100

  • Dr. Guenther Heytmanek

    Vienna, 1030

  • Dr. Ewald Boschitsch

    Vienna, 1060

  • Dr. Brigitte Wiesenthal

    Vienna, 1070

  • Allgemeines Krankenhaus der Stadt Wien Universitätskliniken

    Vienna, 1090

  • Dr. Wolfgang Bartl

    Vienna, 1200

  • Dr. Max Stiglbauer

    Wiener Neustadt, Lower Austria, 2700

  • Dr. Meusburger

    Wolfurt, Vorarlberg, 6922

  • Dr. Walter Paulik

    Zeltweg, 8740

Other trials in Austria

Spain5 sites

  • USP Institut Universitari Dexeus

    Barcelona, Barcelona, 08028

  • Diatros Gava- Centre Assistencial Ntra. Sra. de Burgues

    Gavà, Barcelona, 08850

  • Hospital Universitario MAterno Infantil de Canarias

    Las Palmas, Gran Canaria, 35016

  • Instituto Palacios de Salud y Medicina de la Mujer

    Madrid, 28009

  • Complejo Hospitalario Ntra. Sra. de Valme

    Seville, 41014

Other trials in Spain

About this study

Official title: Multi-center , Open, Uncontrolled Study to Investigate the Efficacy and Safety of a 4 Phasic Oral Contraceptive SH T00658 in a 28-day Regimen for 20 Cycles in Healthy Female Volunteers

The purpose of this study is to evaluate the safety and effectiveness of a new 4-phasic preparation in the prevention of pregnancies in a large group of volunteers.

Read the 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.

Conditions
Contraception
Being tested
EV/DNG (Qlaira, BAY86-5027, SH T00658K)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EV/DNG (Qlaira, BAY86-5027, SH T00658K)Drug

    per cycle (28 days): Days 1-2: 3.0 mg EV; Days 3-7: 2.0 mg EV + 2.0 mg DNG; Days 8-24: 2.0 mg EV + 3.0 mg DNG; Days 25-26: 1.0 mg EV; Days 27-28: Placebo

Study groups in NCT00185289
Study groupRoleWhat they receive
Arm 1ExperimentalNot described
Receives: Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658K)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of unintended pregnancies

    Measured: 20 treatment cycles each consisting of 28 days and follow-up period of 14 days

Secondary outcomes (1)

  1. Adverse event collection

    Measured: 20 treatment cycles each consisting of 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2005 (estimated)
  2. Study startApr 2004
  3. Study completionJul 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
1,392 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00185289
Sponsor's protocol ID
91191
Other IDs
EudraCT: 2004-002098-22, 306660
Status last verified
Jul 2011
First submitted
10 Sep 2005
Last updated
15 Jul 2011
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing EV/DNG (Qlaira, BAY86-5027, SH T00658K) in people with Contraception, run by Bayer at 50 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in Germany, Austria, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of unintended pregnancies (time frame: 20 treatment cycles each consisting of 28 days and follow-up period of 14 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00185289.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2011.

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