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OpenTrials
Completed

NCT Number: NCT00185289

Study to Investigate Efficacy and Safety of a New Oral Contraceptive

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.

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Key information

Conditions

Contraception

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Dr. Max Stiglbauer, Wiener Neustadt, Lower Austria, Austria

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy volunteers

Exclusion criteria

  • Any condition that might interfere the outcomes

Treatment and study plan

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

Primary outcomes

  1. Number of unintended pregnancies

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

Secondary outcomes

  1. Adverse event collection

    Time frame: 20 treatment cycles each consisting of 28 days

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2004
Study completion
2006
First posted
Sep 16, 2005
Registry last updated
Jul 15, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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