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OpenTrials
Completed

NCT Number: NCT00302666

Bleeding Pattern Study

The aim of this study is to evaluate bleeding pattern, cycle control, contraceptive efficacy and safety of this oral contraceptive in two different regimens of intake.

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Key information

Conditions

Oral Contraceptive

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Eberbach, Baden-Wurttemberg, Germany

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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 female volunteers aged between 18 and 40 years requiring contraception.

Exclusion criteria

  • Pregnancy or lactation.
  • Any conditions that might interfere with the outcome as well as all contraindications for OC use.

Treatment and study plan

Valette (Dienogest/EE30, BAY86-5038)

Drug

Oral contraceptive extended cycles

Primary outcomes

  1. Bleeding pattern

Secondary outcomes

  1. Safety, contraceptive efficacy

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Comparative, Prospective, Multi-Center, Open, Randomized Study to Investigate Bleeding Patterns, Metabolic Effects, Contraceptive Efficacy, Acceptance, and Safety of an Oral Contraceptive Containing 0.03 mg Ethinylestradiol and 2 mg Dienogest, in Two Different Regimens of Intake (Four Extended Cycles of 84 Days Each Versus the Conventional Regimen of 21 Days) in Healthy Volunteers

Important dates

Study start
2003
Study completion
2005
First posted
Mar 14, 2006
Registry last updated
May 18, 2009

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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