Bleeding Pattern Study

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00302666
First received: February 23, 2006
Last updated: May 15, 2009
Last verified: May 2009

February 23, 2006
May 15, 2009
June 2003
Not Provided
Bleeding pattern
Same as current
Complete list of historical versions of study NCT00302666 on ClinicalTrials.gov 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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1315
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.
Female
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00302666
91227, 306903
Not Provided
Therapeutic Area Head, Bayer Schering Pharma AG
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
May 2009

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