Bleeding Pattern Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00302666
Recruitment Status : Completed
First Posted : March 14, 2006
Last Update Posted : May 18, 2009
Information provided by:

February 23, 2006
March 14, 2006
May 18, 2009
June 2003
Not Provided
Bleeding pattern
Same as current
Complete list of historical versions of study NCT00302666 on Archive Site
Safety, contraceptive efficacy
Same as current
Not Provided
Not Provided
Bleeding Pattern Study
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
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.

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.

Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Oral Contraceptive
  • Drug: Valette (Dienogest/EE30, BAY86-5038)
    Oral contraceptive extended cycles
  • Drug: Valette (Dienogest/EE30, BAY86-5038)
    Oral contraceptive conventional cycles
  • Sham Comparator: Arm 1
    Intervention: Drug: Valette (Dienogest/EE30, BAY86-5038)
  • Sham Comparator: Arm 2
    Intervention: Drug: Valette (Dienogest/EE30, BAY86-5038)
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Not Provided
February 2005
Not Provided

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.
Sexes Eligible for Study: Female
18 Years to 40 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Not Provided
Therapeutic Area Head, Bayer Schering Pharma AG
Not Provided
Study Director: Bayer Study Director Bayer
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP